Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I'm not entirely certain that the Boceprevir results were that bad. They are filing this year as they said they would so they don't consider anemia a show stopper. And the SVR rates at 48 weeks compared to the control arm is better than that of teleprevir.
Is CYPB still worth $4 without the co-promotion in the minds of investors? Assuming investors valued the company in the mid 2's with co-rights to savella and cyp-1020 it seems to me that, unless the royalty rate is really good, CYPB will be valued where it was before Ramius came into the picture. Considering that CYPB hasn't even mentioned the rate in the PR it would appear that the royalty rate is nothing to shout about. What could Ramius do at this point? CYPB has repeatedly asserted that they want to focus on cyp-1020 and that is something ramius clearly does not want to do.
I meant a sharp sell off. The offer from Ramius is obviously going to be rejected and I can't imagine Ramius remaining as a shareholder. The company will also spend money on CYP-1020 and royalties are unlikely to make up for that cost.
I'm somewhat surprised that the pre-market reaction to this news hasn't been similar to that after licensing cyp-1020.
Cypress Bioscience Announces Agreement to Discontinue Co-Promotion of Savella(R) With Forest Laboratories
Withdrawal From Commercial Market Will Result in Annual Savings of $10 Million
Press Release Source: Cypress Bioscience On Wednesday August 4, 2010, 6:30 am
SAN DIEGO, CA--(Marketwire - 08/04/10) - Cypress Bioscience, Inc. (NASDAQ:CYPB - News), a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system disorders, today announced that it is discontinuing its rights under its agreement with Forest Laboratories to co-promote Savella®, its drug for fibromyalgia. Forest has agreed to pay Cypress a one-time payment of $2.0 million to help facilitate with this transition. Cypress will retain all other rights under its agreement with Forest including its royalty on Savella sales and may pursue the opportunity to re-activate the co-promotion right through discussions with Forest in the future. Forest will maintain promotional levels behind Savella.
In an effort to further reduce its cost structure, Cypress will also either discontinue or sell its personalized medicine services business by the end of Q3'2010. Cypress estimates that these actions will decrease its operating costs by approximately $10 million on an annualized basis. Operating results for the remainder of 2010 will be adversely affected by charges related to severance payments and termination of contractual obligations, which the company currently estimates will be approximately $3.5 million and up to approximately $1.0 million in impairment charges.
Additionally, Cypress will be decreasing its workforce by approximately 86% affecting 123 of its employees. Concurrent with this announcement, all affected employees will receive appropriate notice of the lay off to be effective October 6, 2010.
"While this type of action is very difficult, the board of directors and the management team believe it is in the best interest of CYPB shareholders that we preserve cash resources while focusing on our strongest opportunities for success," said Jay D Kranzler, MD, PhD, Chairman and Chief Executive Officer of Cypress Bioscience. "Our withdrawal from the commercial market has been contemplated for some time now and is part of our renewed strategic focus on CNS drug development." {Looks like middle finger to ramius}
Physician orders for the company's Avise(SM) personalized medicine services will continue to be performed; however, active marketing of these products will be discontinued with the elimination of sales operations. The company is actively engaged in efforts to secure a buyer for its personalized medicine services business.
http://finance.yahoo.com/news/Cypress-Bioscience-Announces-iw-465663937.html?x=0&.v=1
What was said on CNBC about ARNA? Can't see any mention on the news wire.
Great call tony11. ARNA just touched 8. Must be driving AF nuts.
If SNY is not planning on launching a generic that appears to imply that they are confident about retaining a decent share of the US market. If they suspected that m-enox would capture around 80 % of the market it doesn't seem logical not to launch an AG.
If SNY stayed the course and took only a 20% share of the approximately 3B us market, that accounts for about 600 M. If they launched an AG and the AG had a discount of say 25% and captured 50% of the market then thats about 1.125 B minus licensing. Branded lovenox sales will probably be a negligible percentage.
So if SNY is not planing to launch an AG they are either assuming that they would retain about 40-50 % of the market. Is there any other logical reason for SNY to not launch an AG?
I'll try to give a preemptive answer. I assume you are referring to SNY essentially having given up on US sales being anything meaningful as obviously being bullish for mnta.
Thanks DD. FWIW I also found this on wiki which provides 2 other possible reasons.
"In the United States, in order to obtain a temporary restraining order, a plaintiff must prove four elements: (1) likelihood of success on the merits; (2) irreparable harm,absent the order; (3) that less harm will result to the defendant if the TRO issues than to the plaintiffs if the TRO does not issue; and (4) that the public interest, if any, weighs in favor of plaintiff.[1] If the balance of hardships tips in favor of plaintiff, then the plaintiff must only raise "questions going to the merits so serious, substantial, difficult and doubtful, as to make them fair ground for litigation and thus for more deliberative investigation."[2]"
http://en.wikipedia.org/wiki/Temporary_restraining_order#Temporary_restraints
For the TRO to have been issued, would sandoz/mnta have had to show that the FDA made the wrong decision or would they have had to show that the FDA's decision was harmful to their business or both? TIA.
If I understand correctly, are you and biomaven saying that the FDA would make a decision on the TEVA ANDA based on the low discount for m-enox? That seems improbable and is completely out of the FDA's mandate.
That "poor old soul" was probably a smart investor keeping on eye on the FDA homepage. The FDA posted a release announcing the approval that morning. The FDA probably needs to rethink this policy of surprising the market as well as the affected biotech companies with press releases when the market is open.
If SNY does decide to go with an AG any guesses on how long it would take for the AG to enter the market and who the likely candidate to produce the AG would be? TIA
BTW on the subject of TEVA's ANDA if it is held in limbo for a while and then approved Sandoz would benefit tremendously since m-enox would already have captured a substantial portion of the market by then and they would have a higher take of the revenues because of the multiple generics clause. MNTA should prbly have had a clause in the agreement with regard to market share ie if m-enox share of the lovenox pie was greater than 50% they would get a bigger share or something along those lines.
Edit : Of course the reduction in revenue as a result of the competition would have to be considered but that will likely to be smaller than the percentage of revenue sandoz would get if another generic is approved.
Regarding MNTA valuation, when one considers the multiple generic case or the AG case, the price reduction due to the competition has to be factored in.
So as an example if m-enox and lovenox are the only competitors then m-enox could have a 25% price reduction and the 50% share you hypothesized for m-enox will have to reduced by 25%, though 50% is likely too low of a market share. If Teva's generic gets approved and then SNY launches an AG, then there will be further price reduction and smaller market share to m-enox.
I think the current economy and the drive to reduce health care costs will be beneficial to m-enox and it could capture a substantial portion of the lovenox market.
I must have missed the posts addressing the legal challenges m-enox will face. are these potential challenges even a credible threat? Surely a judge can't have more scientific credibility than the FDA. IMO if enthusiasm is muted it will be because of the potential of Teva's application being approved followed by SNY launching an AG and then competition from other anticoagulents like rivaroxaban and apixaban.
Regarding the CP, the FDA approved one part of the petition, that generic lovenox contain the 1,6 anhydro ring structure (whatever that means). Do you know if that requirement automatically disqualifies TEva's application? They seemed pretty confident in a PR they released friday so I assume they do meet that requirement.
Apparently SNY is interested in GENZ per WSJ
MNTA - Here's the FDA link if anyone is interested.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm
Clinical / Regulatory / Litigation Calendar
[Please keep these entries up to date! See
the updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: CHTP
ABT – Certriad (Crestor+TriLipix): response to FDA’s CRL (issued 3/30/10) expected any day (source: 2Q10 CC).
ABT – Bioresorbable DES: EU launch expected 2013 (pending successful pivotal trial); no guidance yet on US launch.
ACHN – ACH-1625: start phase-2a trial Sep 2010.
ACHN – ACH-1095: IND filing late 2010.
ACHN – ACH-2684: IND filing 2011.
ADLR-ADL5849 and 5747 (osteoarthritis) p2a 3q10
ADLR-ADL5747 (post-herpetic neuralgia) p2a early 2011
AGN – Trial of lawsuit vs FDA began 4/7/10.
AGN – Botox for migraine PDUFA date (from standard review) July 2010.
AGN – Botox for OAB: sBLA submission 2H10 (no PR planned for top-line data).
AGN – Next-gen neurotoxin for pain: start phase-2 in 2010.
AMGN – Denosumab: Already approved by FDA and EU for treatment of osteoporosis; PDUFA date for BLA in treatment of bone mets 11/18/10; data from phase-3 trial to prevent bote mets in HRPC (http://clinicaltrials.gov/ct2/show/NCT00286091 ) 4Q10; BLA submission for bone health in non-metastatic cancer 2012-2013.
AMLN – Bydureon (exenatide LAR) second-pass PDUFA date 10/22/10. (Original CRL issued by FDA 3/15/10.)
ANDS – ANA598 phase-2a trial: SVR12 data for patients re-randomized to 12 weeks of SoC: 3Q10 (200mg cohort), 4Q10 (400mg cohort); SVR12/SVR data for patients re-randomized to 24 weeks of SoC: 1H11.
ARNA – Lorcaserin PDUFA date 10/22/10; FDA advisory panel tentatively 9/16/10.
Bayer – Xarelto: see JNJ.
Bayer – VEGF Trap-Eye: see REGN.
BMY – Apixaban in AF/stroke prevention: data from phase-3 AVERROES (non-warfarin) study will be presented at ESC 8/31/10.
BMY – Apixaban in VTE prevention: European MAA any day (was supposed to be 1H10); FDA submission uncertain.
BMY – Ipilimumab in second-line metastatic melanoma (the indication presented at ASCO 2010): BLA submitted in Jun 2010—FDA decision on priority review Aug 2010; European MAA submitted and accepted by EMA for review.
BMY – Ipilimumab in first-line metastatic melanoma: data from phase-3 ‘024’ trial testing DTIC±Ipi expected 2H10.
BMY – Ipilimumab in melanoma brain mets: OS data from phase-2 ‘042’ trial 2011 (RR data reported at 2010 ASCO).
BMY – Ipilimumab in NSCLC/SCLC: OS data from phase-2 ‘041’ trial 2011 (PFS data for NSCLC reported at 2010 ASCO). Decision has been made to advance to phase-3 in NSCLC (source: 2Q10 CC).
BMY – Sprycel in first-line CML: PDUFA date 10/28/10.
BPAX – LibiGel: complete enrollment of phase-3 efficacy trials mid 2010; complete enrollment of phase-3 safety trial 4Q10 (maybe).
CHTP - Droxidopa in NOH PIII Study 301 : Enrolled last patient end June. Results due September 2010.
CHTP - Droxidopa in NOH in Parkinsons pts only PIII Study 306 : Results due Q2 11.
CORT – Corlux: last patient will be dosed next week, efficacy results 4Q10, timeline slip for NDA submission to 1Q11: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=51692765
CORT - CORT 108297 Phase I initiated in February, original guidance was for 2Q10 completion. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46958126
ELN – Bapineuzumab: see JNJ.
ELN – ELND005 for AD: phase-2 final data 1H10? (The two highest doses were dropped due to toxicity on 12/15/09.)
GILD – Quad: complete enrollment of first phase-3 Quad trial Jul 2010 (trial started Apr 2010). Report 48-week (final) phase-2 data from Quad-vs-Atripla study and GS9350-vs-ritonavir study at unspecified medical conference 2H10. (Bare-bones 24-week data from both studies were reported on 1/6/10.)
GILD – Standalone Elvitegravir: report phase-3 Elvitegravir-vs-Isentress primary-endpoint (48-week) data early 2011.
GILD – TMC278+Truvada combo pill: submit NDA/MAA 4Q10. GILD will submit the NDA as soon as the FDA accepts JNJ’s TMC278 NDA for review; bioequivalence studies were completed 4/27/10. (See JNJ for further TMC278 info.)
GILD – GS9190+GS9156 all-oral cocktail: complete phase-2a and start phase-2b 3Q10; report (28-day) phase-2a data trial at 2010 AASLD.
GILD – Standalone GS9190: report phase-2b data 3Q10.
HGSI – Benlysta in SLE: applications were submitted to the FDA and EMEA on 6/10/10 and 6/4/10, respectively. No reply yet wrt to granting of FDA priority review.
HGSI – Zalbin (Albuferon): PDUFA date is nominally 10/4/10, but the BLA will presumably be withdrawn based on HGSI’s 6/14/10 disclosure that approval is hopeless. (European MAA was withdrawn on 4/19/10 after a negative initial review.)
HRBR – Triolex for obese insulin resistant patients: data from obese cohort released and notice of new studies on specific effects on liver and muscle glucose uptake:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=49963156
IDIX – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52041831 .
INHX – INX-189 HCV polymerase inhibitor: complete phase-1 late 3Q10; start phase-1b 3-day monotherapy trial early 4Q10; prelim data from phase-1b late 4Q10; final data from phase-1b early 2011.
ITMN – ITMN-191/RG7227: see Roche.
ITMN – Esbriet (pirfenidone): FDA issued a CRL requesting a new trial on 5/4/10; EMEA initial response to MAA soon (MAA submitted 3/2/10, initial response had been expected early Jul 2010).
JNJ – Bapineuzumab: ‘301’/‘302’ (N. American) phase-3 trials conducted by JNJ: data in 2H12; int’l phase-3 trials conducted by PFE: data in 2014 (confirmed on PFE’s 1Q10 CC).
JNJ – Nevo drug-eluting stent: EU submission late 2010; FDA submission 2012.
JNJ – PurTox botulinum toxin: submit BLA 4Q10 after completing two phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)
JNJ – Telaprevir: see VRTX.
JNJ – TMC278 for HIV: present phase-3 data at medical conference 7/22/10; submit NDA/MAA 3Q10. (See GILD re TMC278+Truvada combo pill.)
JNJ – Xarelto: reply to FDA’s CRL received in May 2009: late 2010 (source: 2Q10 CC).
LLY – Bydureon: see AMLN.
MDVN – Dimebon: see PFE.
MNTA – See
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52465476 .
MRK – Boceprevir NDA late 2010 (according to disclosures at MRK’s annual R&D Day on 5/11/10).
MRK – Isentress sNDA submission for qD dosing in treatment-experienced setting: 2011.
MYRX - Azixa (GBM w/ carbo) p2 data 1h10
MYRX - Azixa (metastatic melanoma w/ temoz) p2 data 1h10
MYRX - MPC4326 (HIV) p2b complete 1q11
NVS – Gilenia (f/k/a FTY720): PDUFA date 9/21/10; EU MAA submitted late Dec 2009. (FDA advisory panel voted 25-0 in favor on 6/10/10.)
NVAX – H1N1 VLP vaccine 1,000 patient “stage A” trial in Mexico data complete and submitted to Mexican authorities. 3500 patient “stage B” completed enrollment in early March: http://finance.yahoo.com/news/NOVAVAX-Announces-Positive-prnews-4040674703.html?x=0&.v=1
NVAX – BARDA funding decision awaits site inspection… update in conference call, site inspection complete.
http://finance.yahoo.com/news/NOVAVAX-Notified-by-prnews-1260458837.html?x=0&.v=1
NVAX – seasonal trivalent head to head phaseIIb vs. Fluzone. see:
http://finance.yahoo.com/news/Novavaxs-Seasonal-Influenza-prnews-3904001081.html/print?x=0
ONTY – Phase-3 trial in Stage III NSCLC: first interim analysis (at 50% of deaths relative to trigger for final analysis): 2H10.
OREX – Contrave NDA: FDA advisory panel 12/7/10, PDUFA date 1/31/11.
PFE – Apixaban: see BMY.
PFE – Bapineuzumab: see JNJ.
PFE – Dimebon: AD program terminated 5/10/10 except the CONCERT study testing Aricept±Dimebon in mild-to-moderate AD. HORIZON study in HD continues.
REGN - Rilonacept in flare prevention upon initiation of allopurinol - results expected in 2010; Rilonacept in flare treatment - results expected in 2010.
REGN - Aflibercept in 3 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred)
REGN - VEGF Trap-Eye: results from ph-3 trials in AMD 4Q10.
Roche – ITMN-191/RG7127 with SoC: Report data from Part A of phase-2b SoC ± unboosted ITMN-191 at a medical conference in 1H10. (Part B of this study has been cancelled.) Report complete dataset from phase-1b trial with ritonavir 1H10, presmably at the same conference. *New* phase-2b trial of SoC ± ritonavir-boosted ITMN-191 starts 3Q10 (but I’m skeptical it will start at all—Dew).
Roche – RG7128 with SoC: 12-week phase-2b in geno-1/4 completed enrollment and 24-week phase-2b in geno-1/4 *started* enrollment during Feb 2010. Phase-2b in geno-2/3 will start 2H10.
Roche – INFORM-n series of all-oral HCV trials: INFORM-2 trial has been canceled; start INFORM-3 with SVR endpoint 2H10 (maybe).
SPPI - Belinostat (CUP w/ chemo) p2 data by ye10
SPPI - Belinostat (PTCL monotherapy) NDA 2011
TEVA – Copaxone patent litigation: see MNTA.
TEVA –“Low-volume” Copaxone: PDUFA date Jan 2011.
TEVA – Thrice-weekly formulation of Copaxone: study to start recruiting patients soon (http://clinicaltrials.gov/ct2/show/NCT01067521?term=gala+copaxone&rank=1 ).
TRBN - TRU015 (RA) 1st p2b re-treatment add'l data 11/10 at ACR
2nd p2b final data 11/10 at ACR
VRTX – Telaprevir+SoC: phase-3 ILLUMINATE trial in 1st-line setting: SVR data 3Q10 (top-line data from the ADVANCE study was reported 5/25/10); phase-3 REALIZE trial in 2nd-line setting: SVR data 3Q10; NDA in first- and second-line settings: 4Q10.
VRTX – Telaprevir + VX-222: report phase-2 interim safety, efficacy, and PK data 2H10; SVR data 1H11.
VRTX – VX-509 JAK3 inhibitor: phase-2 interim data 2H10 (trial started Jan 2010).
VRUS – RG7128 and INFORM-n series of trials: see Roche.
VRUS – PSI-7977: present final phase-2a data at conference in 2H10, presumably AASLD (top-line results were reported via presented 5/4/10); start 12-week phase-2b trial 4Q10.
VRUS – PSI-938: report phase-1 data 3Q10.
VRUS – PSI-661 (f/k/a PSI-879): file IND/CTA 4Q10.
VVUS – Qnexa PDUFA date 10/28/10. (Negative vote at advisory panel 7/15/10.)
ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical order.
3. Near the top of the message, list the ticker symbols of the entries you changed (e.g. “Edits: GILD IDIX MNTA”).
I stand corrected about the PII OS data being equivalent between the two study arms. I think i mistook the safety data with the OS data. Here is the full quote.
Yes I agree. Is this the likely reason for the FDA delay and if so what are the chances that the FDA issues a positive ruling if they can't even get access to manufacturers of raw hep?
ZIOP - There is no indication of the power of the trial for the OS endpoint. I think after the avastin decision mgmt should be concerned enough about what the FDA would do even with robust PFS results if the OS endpoint is not statistically significant. The PR from the ASCO presentation indicated OS was somewhat equivalent to the control arm.
China Never Investigated Tainted Heparin, Says Probe
JULY 22, 2010
By ALICIA MUNDY
WASHINGTON—The Chinese government didn't pursue an investigation into contaminated heparin sent to the U.S. in 2007 and 2008, despite repeated requests from the U.S. for help, according to a congressional probe.
Two House Republicans said Food and Drug Administration officials recently told them that the agency has been "severely hampered" by the lack of cooperation from China in finding those responsible. Contamination in the widely used blood-thinner was linked to at least 81 deaths in the U.S.
The probe by Reps. Joe Barton and Michael Burgess, both of Texas, comes as FDA Commissioner Margaret Hamburg prepares for her first trip to China since assuming her post last year.
"It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why," said Mr. Barton, the top Republican on the House Energy and Commerce Committee. He called on Ms. Hamburg to air the issue with Chinese officials.
Yan Jiangying, spokeswoman for China's State Food and Drug Administration, said the congressmen's accusations are "not true."
Ms. Yan said her agency "did a very thorough investigation, including very detailed inspection and testing, and surveys of enterprises as well. We signed an agreement with the FDA on drug safety in the end of 2007, and strengthened the monitoring of heparin."
A spokeswoman for the FDA said Wednesday that "there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government."
In a June 16 letter to the congressmen, the FDA wrote that it was "denied full access" to manufacturers of raw heparin in China.
Mr. Barton and Mr. Burgess said the FDA told members of Congress that China hasn't had any breakthroughs in the investigation, which they said left the "misleading impression" that "there was some kind of open investigation."
In fact, Chinese security authorities told a U.S. official in Beijing on June 18, 2008, that China wasn't investigating the heparin issue as either a criminal or administrative matter, according to the congressmen.
Write to Alicia Mundy at alicia.mundy@wsj.com
http://online.wsj.com/article/SB10001424052748703954804575381540372921432.html
What are the chances that the FDA only approves use of Avastin with paclitaxel and not with any other chemo?
Genetic testing mix-up reignites debate over degree of federal regulation needed
By Rob Stein
Washington Post Staff Writer
Saturday, July 17, 2010
One woman panicked when the genetic test she had ordered over the Internet concluded that her son was carrying a life-threatening disorder and, even more disturbing, that he was not -- genetically -- her son. Another, who always thought she was white, was flabbergasted to find her genes were mostly of African origin. A third woman's result was still more stunning: She was a man, it said.
"I thought, 'Oh my God. Am I really a man?' " said Denise Weinrich, 48, of St. Peters, Mo. "I thought, 'What's the matter with me? I'm not who I thought I was. How am I going to tell my children?' DNA doesn't lie."
DNA does not lie, but its truth is often elusive. Weinrich was one of 87 people who received incorrect results last month because of a laboratory mix-up involving customers of 23andMe, a testing company backed in part by Google. The Mountain View, Calif., testing company says it regrets the incident and noted that it spotted the mistakes quickly, notified the clients and has taken steps to prevent future errors.
But the blunder has fueled a debate over whether the government should more aggressively police the proliferating tests. Critics say that too many make claims that go far beyond the science, yield results too complicated for people to interpret on their own or are just plain wrong. Others, however, fear that more federal oversight will make the tests too expensive and hard to get.
"If you have things completely unregulated, then you have a Wild West of commercial interests around medical information," said Robert C. Green, director of Boston University's Center for Translational Genomics and Health Outcomes. "If you over-regulate, you run the risk of stifling innovation in a very dynamic industry."
Genetic testing has become one of the flash points in the larger question raised by new technologies that are fueling a movement toward more unfettered access to information: When does government intervention cross from prudent and necessary to intrusive and paternalistic?
Dozens of companies offer tests that claim to tell people everything from what foods they should eat to live longer and what cosmetics they should use to whether they are at risk for cancer, Alzheimer's and other ailments. Many think that genetic testing is key for the future of "personalized medicine," which tailors cures to people's genes. But few tests have undergone stringent scientific validation.
Mounting concerns have prompted the Food and Drug Administration, which has long resisted calls to regulate the field, to begin stepping in. In May, the agency scuttled plans by Pathway Genomics of San Diego to sell genetic tests in Walgreens stores. Several weeks later, the FDA sent letters to five companies that were selling tests over the Internet, declaring that their kits are medical devices and must undergo federal scrutiny. Next week, the agency is convening a public hearing to debate what regulatory role it should play.
"It's come to the point where really there's a need for some oversight," said Alberto Gutierrez, who heads the FDA's Office of In Vitro Diagnostics. Results from questionable tests can be unnecessarily alarming, Gutierrez said, adding that some women have undergone surgery, for example, based on tests that purport to gauge the risk for ovarian cancer.
"We know of reports of people who have found a test, found a doctor that is willing to order the test since they are so afraid of the disease, and even removed ovaries based on questionable results," Gutierrez said.
'My nightmare scenario'
What's more, without a genetic expert to interpret the often-nuanced results of valid tests, patients who test negative might be falsely reassured, critics argue. Women might think they are safe from breast cancer, for example, and stop getting mammograms without realizing that they might still be in danger because of genes not included in the test or other factors.
"That's my nightmare scenario," said Hank Greely, director of Stanford University's Center for Law and the Biosciences. Even when the results are accurate, public perceptions often exaggerate the current power of genetic testing, many experts say.
"What one hears frequently is that simply knowledge of one's various risks is a 'road map to better health.' That is profoundly inaccurate and premature," said James Evans, a professor of genetics and medicine at the University of North Carolina in Chapel Hill. "We have little, if any, evidence that the provision of such information actually results in better health."
The FDA did not want to specify what action the agency will consider at next week's hearing.
Registry for consumers
The National Institutes of Health is creating a registry to help consumers learn what genetic tests are available and evaluate their scientific validity. But signing up is voluntary for companies, and some experts argue that the first step should be to make the registry mandatory.
"What I think we need is greater transparency and information-gathering about tests on the market, how that information is being reported to patients and how patients or doctors are using that information," said Daniel Vorhaus, an attorney who edits the Genomics Law Report, an online publication.
The tests provide people with information that motivates many to take steps to protect their health, others say, noting that laboratories are regulated through the federal Centers for Medicare and Medicaid to guarantee basic proficiency. The already-stretched FDA could become overwhelmed if it took on the task of going further and verifying the complex science underlying many of the tests' claims, they argue.
"While regulations are sometimes necessary to protect consumers, people also need to remember that they come at a cost," said Daniel MacArthur, who writes about genetic testing on his blog, Genetic Future.
Advocates for patients suffering from rare diseases are especially concerned that companies will have little financial incentive to develop tests if increased regulation makes them too costly.
"The risk of losing these tests is significant," said Michael S. Watson of the American College of Medical Genetics.
The prospect of greater FDA regulation is being met with mixed reaction by companies. Officials from several said they welcome reasonable new controls that might help eliminate less-scrupulous hawkers. Some also expressed concern about interference with the public's access.
"If you look back a few decades, people were not told about their diagnosis of cancer, and it was thought we need to protect them from that information. Now that seems ridiculous," said Joanna Mountain, senior director of research at 23andMe, which was co-founded by Anne Wojcicki, wife of Google's Sergey Brin. "The same thing goes for genetic information. We have many, many people who are very, very curious and want to know and are capable of handling this information."
Limited scrutiny sought
Some hope the FDA will opt to regulate only those tests that would lead to important medical decisions and not those supposedly proffering more benign information.
"If the test is for curly hair, then that shouldn't rise to the level of requiring FDA review," said Sharon Terry of Genetic Alliance, a Washington-based coalition of patient groups, researchers, private companies, government agencies and public-policy organizations. "If the test is for whether I'm at risk for Alzheimer's disease, then that should undergo FDA scrutiny."
Even many of the customers who received false results from 23andMe last month oppose greater regulation.
"Why should other people be able to tell us we can't have information about our own genes?" said CeCe Moore, a California TV producer whose niece got the false information about her race. "Nothing is more personal."
http://www.washingtonpost.com/wp-dyn/content/article/2010/07/16/AR2010071606246.html
FYI - Savella sales was 20.5 million.
http://finance.yahoo.com/news/Forest-Laboratories-Inc-bw-4248315449.html?x=0&.v=1
I'm not referring to the value of the deal, rather the terms of the deal. Ramius has clearly indicated that development of cyp-1020 won't continue unless funding comes from elsewhere. Since CYPB mgmt have an outstanding deal with BiolineRX, they would likely have to terminate that deal if they go with Ramius's offer. So any deal on the table has to include money to either finance the drug or to terminate the deal. It seems to me that this offer has a few hurdles that may be too high to overcome.
And if this deal falls through one has to consider what Ramius would do with the 10% of shares they are holding.
Pfizer Halts Tanezumab Studies For Back Pain, Diabetes
JULY 19, 2010, 5:20 P.M. ET
DOW JONES NEWSWIRES
Pfizer Inc. (PFE) has suspended studies of its drug tanezumab for treating chronic low back pain and nerve damage caused by diabetes at the request of the Food and Drug Administration.
But it will continue to test the drug in some areas, such as for cancer pain.
The world's largest drug maker said the FDA request came after reports of side effects in osteoarthritis patients taking tanezumab and because the agency was worried about the potential for similar effects in other patients taking the drug.
Pfizer last month had announced the suspension of tanezumab studies in patients with osteoarthritis, or low back pain. At that time, Credit Suisse said experts had suggested the drug's relief was so effective it led to patients overusing their joints, causing them to require joint replacements earlier than otherwise expected.
Before the studies were halted, Pfizer had called the drug a potential blockbuster.
The company said Monday that it will continue to work with the FDA to determine the scope of continued clinical trials of tanezumab.
Its shares were at $14.65, down 0.5%, in after-hours trading.
-By Kathy Shwiff, Dow Jones Newswires; 212-416-2357; Kathy.Shwiff@dowjones.com
http://online.wsj.com/article/BT-CO-20100719-712738.html
Is there a link or source for this information?
CYPB - Any thoughts whether this deal is likely to go through? Clearly Ramius doesn't think highly of cyp-1020 and doesn't want to fund cyp-1020 so CYPB will have to find money from elsewhere. If money can't be found elsewhere what would happen to the deal with biolinerx if the buyout goes through? Since CYPB owes them money per the agreement to develop cyp-1020, i imagine mgmt would have to refuse the deal from ramius?
CYPB - Ramius Offers to Acquire Cypress Bioscience for $4.00 Per Share in Cash
Offer represents a 60% premium over the last closing price and 74% premium over the average closing price since the acquisition of BioLineRx’s BL-1020 drug
Expects Cypress Board to immediately hire a reputable investment bank to evaluate its offer and to formally explore a sale of the Company
Demands Board cease and desist from approving any further acquisitions given ongoing destruction of shareholder value
Press Release Source: Ramius LLC On Monday July 19, 2010, 7:45 am
NEW YORK--(BUSINESS WIRE)--Ramius Value and Opportunity Advisors LLC, a subsidiary of Ramius LLC (collectively, “Ramius”), today announced that it has sent a letter to the Board of Directors of Cypress Bioscience, Inc. (“Cypress” or “the Company”) (NASDAQ: CYPB - News) outlining an offer to acquire all of the outstanding shares of the Company that it does not already own for $4.00 per share in cash. The Ramius offer described in the letter represents a 60% premium over the July 16, 2010, closing price and a 74% premium over the average closing price since the acquisition of BioLineRx’s BL-1020 drug. Ramius currently owns 9.9% of the outstanding common stock of Cypress, making it one of the Company’s largest shareholders.
In addition to the all-cash offer, Ramius also stated in the letter that it would be willing to consider an acquisition structure that would allow management to continue the development of the recently acquired BL-1020 if they are able to fund the required financing for the Phase IIb trial themselves or from a third party financing source. As part of this structure, Ramius believes management and third party financing could retain a 50% interest in BL-1020, with the other 50% interest retained on a pro-rata basis by all existing Cypress shareholders. Ramius believes that this structure would provide shareholders with immediate liquidity through an all-cash acquisition at a significant premium to the current stock price and provide shareholders with an opportunity to retain future upside potential from the development of BL-1020 without shareholders funding the risk.
Further, Ramius stated that ill-conceived acquisitions and other internal investments proposed and executed by management and supported by the current Board have resulted in significant destruction of shareholder value and that the Board should immediately hire a reputable investment bank to explore a sale of the Company. Ramius notes that it is currently evaluating all legal options and reserves its right to take any action necessary to ensure that Cypress is run in a manner that is consistent with the best interests of all shareholders.
Ramius Partner Managing Director Jeffrey C. Smith, stated “The Cypress Board needs to realize that a management team that continues to destroy shareholder value by making increasingly risky investments with shareholder money is not a management team to follow blindly. The correct conclusion at this juncture is to stop, hire a reputable banker, and maximize value for all shareholders.”
Mr. Smith continued, “Our all-cash offer provides shareholders with a better alternative to the Company’s current plan of pursuing highly-speculative acquisitions that could continue to destroy significant shareholder value. As such, we are prepared to enter into immediate discussions with the Board around structuring a transaction that maximizes value for all shareholders.”
The full text of the letter follows:
July 19, 2010
TO: Mr. Roger L. Hawley
Dr. Amir Kalali
Dr. Jay D. Kranzler
Mr. Jon W. McGarity
Mr. Jean-Pierre Millon
Dr. Perry B. Molinoff
Dr. Tina S. Nova
Mr. Daniel H. Petree
To the Board of Directors of Cypress:
Ramius Value and Opportunity Advisors LLC, together with its affiliates, (“Ramius”), propose to acquire all of the outstanding shares of common stock of Cypress Bioscience, Inc. (“Cypress” or the “Company”) that we do not already own at a price of $4.00 per share in cash. Ramius currently owns approximately 9.9% of the outstanding common stock of Cypress, making us one of the largest shareholders of the Company. We are ready, willing, and able to close this transaction expeditiously and expect the Board of Directors (the “Board”) to retain a reputable investment bank to immediately engage in discussions with us and any other potential acquirers to maximize value for all shareholders.
Up until now, we believe the current Board has shown a complete disregard for the best interests of all shareholders and its fiduciary duty to maximize shareholder value. We are currently evaluating all legal options and reserve our rights to take any action necessary to ensure that Cypress is run in a manner that is consistent with the best interests of all shareholders. We implore the Board to cease and desist from approving any further acquisitions and not enter into, or seek or propose to enter into, any further material transactions, licensing agreements or business combinations that could jeopardize the ability for shareholders to realize full and fair value for their investment.
It is incumbent on all directors to now realize that their fiduciary obligations are to maximize value for all shareholders. Our offer is real, and provides a substantial premium to the market price of the Company.
Ramius Offer:
Our all-cash proposal of $4.00 per share represents a 60% premium over the last closing price of $2.50 per share, and a 74% premium to the average closing price of $2.30 per share since the announcement of the acquisition of BioLineRx’s BL-1020 on June 21, 2010. In addition to the all-cash offer, if management is so convinced that BL-1020 is likely to be successful, we are willing to consider an acquisition structure that would allow management to continue the development of BL-1020 if they are able to fund the required financing for the Phase IIb trial themselves or from a third-party financing source. As part of this structure, we would envision management and third-party financing retaining a 50% interest in BL-1020, with the other 50% interest retained on a pro-rata basis by all existing Cypress shareholders. This would be in addition to the $4.00 per share in cash to all shareholders. We believe that this structure would provide shareholders with immediate liquidity through an all-cash acquisition at a significant premium to the current stock price and provide an opportunity to retain future upside potential from the development of BL-1020 without shareholders funding the risk. Our acquisition proposal is conditioned upon satisfactory completion of limited due diligence (which we expect to be confirmatory provided the Board does not take any value-destroying actions), the waiver of any Company anti-takeover provisions, and the execution of a mutually acceptable definitive agreement which will include customary conditions for a transaction of this type and size. Further, the value of our proposal is based on the Company taking no further actions to adversely change the Company’s latest balance sheet and we reserve all rights accordingly. We are prepared to enter into immediate discussions with the Company’s Board of Directors to consummate a transaction.
Management and Board Performance:
We implore the Board to understand that their fiduciary duty is to maximize value for shareholders and that now is the time to hire a reputable investment bank to undergo a sale process in which we will participate. Under the leadership of the current management team and Board, the performance of Cypress has been and continues to be unacceptable to shareholders. This is demonstrated by the significant destruction of shareholder value over the past one, three and five years. As shown in the chart below, Cypress has materially underperformed both the Russell 2000 Index and Nasdaq Biotech Index over those time periods.
Stock Performance
1 Year 3 Year 5 Year
Cypress Bioscience (73.6 %) (81.1 %) (81.8 %)
Russell 2000 Index 16.9 % (28.1 %) (8.0 %)
NASDAQ Biotechnology Index 8.1 % (2.3 %) 6.0 %
We believe this destruction of shareholder value is a direct result of ill-conceived acquisitions and other internal investments proposed and executed by management and supported by the current Board.
Proprius:
On February 25, 2008, Cypress announced the acquisition of Proprius for an upfront payment of $37.5 million with an additional $37.5 million in potential milestone-related payments associated with the development of Proprius’ therapeutic candidates. Prior to the announcement of the acquisition, Cypress’ shares were trading at $7.96 per share and the Company had approximately $182 million in cash. At the time of the acquisition, the stated rationale for the transaction was to generate significant income from product sales and to attract new commercial opportunities in order to leverage the Company’s existing sales force.
“My experience suggests that with proper execution, Cypress’s attractiveness as an in-licensing partner in its specialty segment should increase significantly…yet we believe that even as an independent business proposition, the Proprius diagnostics business could hold its own, as the high-value nature of the offerings are expected to support druglike margins over time.”
- Jay D. Kranzler, CEO (February 25, 2008 Cypress Bioscience investor call).
Based on the publicly reported results since the acquisition of Proprius, the transaction has been a complete failure. In fact, since the acquisition, total revenue from Proprius’ products has amounted to less than $600,000 while costing the Company approximately $40 million in upfront payments and losses. In a recent Company disclosure, management even conceded that the attempt to transition to a commercial business has failed.
“While we have managed to build some value in our attempt to transition to the commercial stage, we have come to the conclusion that our commercial business is not likely to provide a source of sustainable competitive advantage or an opportunity for an optimal return on invested capital.”
- Excerpt from July 12, 2010 8-K filing
The acquisition of Proprius and the decision to be in the commercial business was clearly a mistake and likely a predictable one. Although management’s acknowledgement of this $40 million mistake is a step in the right direction, the hasty decision to jump into high-risk drug development only compounds that prior error. The Board needs to realize that a management team that continues to destroy shareholder value by making increasingly risky investments with shareholder money is not a management team to follow blindly. The correct conclusion at this juncture is to stop, hire a reputable banker, and maximize value for all shareholders.
BioLineRx BL-1020:
On June 20, 2010, Cypress announced that it had entered into an exclusive North American license for the development and commercialization of BioLineRx’s antipsychotic BL-1020. Under the terms of the agreement, Cypress agreed to pay BioLineRx an upfront payment of $30 million, with potential clinical milestone payments of up to $160 million, potential commercial milestone payments of up to $85 million, and potential payments upon additional indications of $90 million. In addition to these payments, Cypress is also responsible to fund all continuing development activity including clinical trials that we believe could cost the Company in excess of $75 million over the next four to five years. All of this is just for the North American rights.
Given the precipitous drop in the Company’s stock price by 38% immediately following the announcement of the BL-1020 acquisition, it is clear that investors do not have confidence in management’s ability to execute on this acquisition and do not believe in the Company’s recently revised strategy to acquire and internally develop highly speculative, early stage drugs. Additionally, the risk of this new strategy has resulted in one analyst that follows the Company already calling for a capital raise in the future.
“between the development costs for ‘1020 and the milestones due to BioLineRx, we would expect the Company will now need to raise capital at least once prior to ‘1020’s potential launch.”
- Oppenheimer Equity Research Report (June 21, 2010).
As discussed before, if management truly believes in the investment merits of BL-1020, we are willing to allow management to share the upside of BL-1020 with the shareholders provided they put in their own money or find third party financing to fund the development so that shareholders do not assume all of the risk.
Fiduciary Responsibility:
It is the fiduciary responsibility of management and the Board to represent the best interests of all shareholders. Given the long history of underperformance driven by ill-conceived acquisitions and failed investments, we believe that management and the current Board may have failed to fully and faithfully represent shareholder interests and discharge their duties. We question whether the members of the Board have breached their respective fiduciary duties to shareholders by continuing to approve highly speculative, overpriced, and value-destroying acquisitions that serve only to further entrench the existing management team and the current Board.
The most recent transaction to acquire BL-1020, which resulted in a one-day stock price decline of 38%, raises further questions about potential conflicts of interest. These potential conflicts include potential relationships between Cypress’ management and the management of BioLine and the role of Cypress’ CEO Dr. Kranzler in advising BioLine on the initial due diligence for BL-1020.
We are evaluating such potential conflicts and the unconventional committee structure of the Board. We seriously question why the Finance Committee, which is comprised of only one director, Daniel Petree, has the sole authority to evaluate, review, facilitate and approve the selection and engagement of financial advisors in connection with strategic transactions, licenses, joint ventures, acquisitions and other similar transactions. We also question the need for the formation of the Strategic Committee in February 2010. According to the proxy, “The Strategic Committee meets with and advises management as the Company considers product licensing, potential acquisitions and other strategic opportunities.” However, the Strategic Committee is comprised of only two board members, Dr. Kranzler, the CEO of Cypress, and Mr. Petree, the sole member of the Finance Committee. Forming the Strategic Committee seems particularly suspect because the Company already has a New Products Committee comprised of five directors who are responsible for evaluating in-license and acquisition candidates. Additionally, we question how the Board can maintain its independence while evaluating new acquisitions when its CEO is part of a two-person committee that advises management on potential acquisitions.
Based on our belief that the Board may have breached its fiduciary duty to shareholders, we are currently evaluating any and all legal options to ensure that the Company does not seek to take any further value destroying measures. We will continue to closely monitor the Board’s actions. To the extent the Board ignores our pleas and continues to pursue additional acquisitions and/or investments, we will not hesitate to take any and all action to protect our investment and the best interests of all shareholders.
Conclusion:
We believe our all-cash offer of $4.00 per share plus the ability to retain upside in the development of BL-1020 if management and/or a third party financing source are willing to fund the ongoing development costs is fair, and provides shareholders with a better alternative to the Company’s current plan of pursuing highly-speculative acquisitions that could continue to destroy significant shareholder value.
We are prepared to enter into immediate discussions with the Board around structuring a transaction that maximizes value for all shareholders.
We fully expect the Board to immediately hire a reputable investment bank to evaluate our offer and to formally explore a sale of the Company.
We expect the Board to cease and desist from allowing management to complete any more acquisitions or any other potentially value-destroying transactions while the Board fully evaluates maximizing value for all shareholders through an expeditious sale process.
We look forward to having productive discussions with you and your advisers to consummate a transaction. In the event that the Board is unwilling to negotiate a transaction that maximizes value for all shareholders, and instead chooses to continue down its current path of destroying shareholder value, we reserve all rights to take any action we deem necessary to ensure the best interests of all shareholders are represented.
Best Regards,
/s/
Jeffrey C. Smith
Partner Managing Director
Ramius LLC
About Ramius LLC
Ramius LLC is a registered investment advisor that manages assets in a variety of alternative investment strategies. Ramius LLC is headquartered in New York with offices located in London, Luxembourg, Tokyo, Hong Kong and Munich.
http://finance.yahoo.com/news/Ramius-Offers-to-Acquire-bw-260356238.html?x=0&.v=1
arna - Piper Jaffray is out with a research report this morning, where it reiterates its Overweight rating on Arena Pharmaceuticals (NASDAQ: ARNA); it also has a $10.00 price target on the stock.
The Piper Jaffray analysts said, “The Phase III BLOOM trial randomized 3,182 obese or overweight patients with co-morbidities to either 10mg BID lorcaserin or placebo for 2 years. At week 52, 856 patients taking lorcaserin were re-randomized 2:1 to continue lorcaserin or switch to placebo and 697 placebo patients stayed on placebo. Dr. Steven Smith of the Florida Translational Research Institute for Metabolism and Diabetes and Dr. Neil Weissman of MedStar Health Research Institute were co-principal investigators. We continue to believe that safety will be the primary focus for FDA review and physician uptake.”
They added, “On an intent-to-treat basis, 47.5% of lorcaserin patients lost at least 5% body weight at 1 year meeting the FDA stated guidelines of "approximately" double the rate of placebo at 20.3% (p<0.001). Further, 22.6% of lorcaserin vs. only 7.7% of placebo patients lost at least 10% body weight. Lorcaserin patients who stayed on drug for a full year lost an average of 18 lbs or 8.2% of their body weight vs. only 7 pounds on placebo. In the second year of the BLOOM study, 67.9% of lorcaserin patients maintained their weight loss vs. 50.3% on placebo (p<0.001).”
The analysts also noted, “Upper respiratory infections, headache, dizziness, nasopharyngitis and nausea were the most common AEs with lorcaserin. Differences in headache and dizziness between groups were less evident in year 2. The incidence of various degrees of depression were only slightly higher with lorcaserin at 3.0% vs. 2.8% on year 2 lorcaserin and 2.0% on placebo. Incidence of suicidal thoughts was 1.3% in both group and SAE rates were similar. BLOOM achieved a 60% power to rule out a 1.5 relative risk of FDA-defined valvulopathy at week 52. This was below the 80% threshold, but Arena submitted pooled data from both studies to the FDA that met the criteria.”
http://www.benzinga.com/analyst-ratings/analyst-color/10/07/377427/piper-jaffray-reiterates-overweight-on-arena-pharmaceutic
OT - Intels results are even more impressive considering AMD had a good quarter as well. I don't see a double dip when corporations are spending on servers.
http://finance.yahoo.com/news/AMD-whittles-2Q-loss-as-chip-apf-3776385818.html?x=0&.v=7
Thats prbly fair if you consider the enterprise value. Doesn't ARNA owe money to deerfield? VVUS has an EV of about 240 M though i don't recall how much debt they have so perhaps its a little more. VVUS has a couple of other indications for qnexa though the safety concerns should carry over for those as well.