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MNTA TRO
Full docket text:
ELECTRONIC Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Motion Hearing held on 10/7/2011 re [18] MOTION for Temporary Restraining Order and Preliminary Injunction filed by Momenta Pharmaceuticals, Inc., Sandoz Inc. The Court temporarily grants [18] Motion for TRO and orders Defendants to temporarily refrain from selling products for 2 weeks. Plaintiff's to submit a draft temporary restraining order by 5:00 PM today, 10/7/2011. This TRO will be enforced for 14 days only, and is subject to amendments at the hearing set for 10/20/11. Defendants are to submit an ex parte document, less than 5 pages, in connection with the adoptions of the TRO. Defendants responsive pleadings are due by 10/12/11. The court will entertain a short memorandum by Plaintiffs justifying the limited and concise amount of discovery, no later than 10/12/11. Further Hearing set for 10/20/2011 11:00 AM in Courtroom 4 before Judge Nathaniel M. Gorton.(Court Reporter: Cheryl Dahlstrom at 617-951-4555.)(Attorneys present: Schou, Marandett, Frank, Steindler, Bauer, Pierce, Hubner, Weir, Robell,) (Patch, Christine)
MNTA TRO
Full docket text:
ELECTRONIC Clerk's Notes for proceedings held before Judge Nathaniel M. Gorton: Motion Hearing held on 10/7/2011 re [18] MOTION for Temporary Restraining Order and Preliminary Injunction filed by Momenta Pharmaceuticals, Inc., Sandoz Inc. The Court temporarily grants [18] Motion for TRO and orders Defendants to temporarily refrain from selling products for 2 weeks. Plaintiff's to submit a draft temporary restraining order by 5:00 PM today, 10/7/2011. This TRO will be enforced for 14 days only, and is subject to amendments at the hearing set for 10/20/11. Defendants are to submit an ex parte document, less than 5 pages, in connection with the adoptions of the TRO. Defendants responsive pleadings are due by 10/12/11. The court will entertain a short memorandum by Plaintiffs justifying the limited and concise amount of discovery, no later than 10/12/11. Further Hearing set for 10/20/2011 11:00 AM in Courtroom 4 before Judge Nathaniel M. Gorton.(Court Reporter: Cheryl Dahlstrom at 617-951-4555.)(Attorneys present: Schou, Marandett, Frank, Steindler, Bauer, Pierce, Hubner, Weir, Robell,) (Patch, Christine)
FWIW, yesterday I posted a long extract from a proposed amended complaint which Amphastar sought to file in late April. The extract contained new allegations about a meeting the FDA scheduled in October 2007 to approve Amphastar's generic. Here's the link:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67313207
I probably should have paid more attention to Amphastar's court filings and considered the "conspiracy theory" possiblity that the FDA might be pressured into approving Amphastar's generic. The Akin Gump firm which represented Amphastar in its suit against the FDA is politically well-connected, having been co-founded by Robert Strauss, who chaired the DNC in the 70s, and having as current partners Vernon Jordan (Clinton Administration) and Tommy Thompson (former Republiican governor).
Fortunately MNTA's lawsuit is based on its process patents as has been pointed out, and it does not attack the FDA approval, which would likely be a losing proposition even if it could be shown that the FDA applied its standards with less rigor in approving Amphastar's generic. IMO, MNTA's suit has much greater upside than downside potential with a good chance of resolution in the not too distant future.
Amphastar filed to amend its complaint in April, based on newly-discovered evidence from a former FDA official who revealed that the FDA called a meeting to approve its generic in October 2007. I have extracted the new paragraphs (## 48 - 60) from the proposed amended complaint relating to the alleged meeting, plus some additional paragraphs from the prior complaint that may have some relevance to MNTA's lawsuit
Amphastar (not surprisingly) has filed for voluntary dismissal in its suit against FDA:
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
AMPHASTAR PHARMACEUTICALS, INC.,
Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, et al.,
Defendants.
Case No. 1:10-cv-01800 (RLW)
NOTICE OF VOLUNTARY DISMISSAL
Pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(i), Plaintiff Amphastar Pharmaceuticals, Inc. hereby voluntarily, and without prejudice, dismisses its claims against Defendants the Food and Drug Administration, Margaret A. Hamburg, and Kathleen Sebelius.
Dated: September 20, 2011 Respectfully submitted,
/s/
Anthony T. Pierce
D.C. Bar No. 415263
Jonathan P. Robell
D.C. Bar No. 493977
Akin Gump Strauss Hauer & Feld LLP
1333 New Hampshire Avenue, N.W.
Washington, D.C. 20036
Telephone: 202.887.4000
Facsimile: 202.887.4288
Counsel for Plaintiff Amphastar Pharmaceuticals, Inc.
Mark Mansour
D.C. Bar. No. 482033
Akin Gump Strauss Hauer & Feld LLP
1333 New Hampshire Avenue, N.W.
Washington, D.C. 20036
Of Counsel
Decision Resoruces study of biosimilar prescription practices.
I do not recall seeing this article posted previously. Assuming the FDA will approve MNTA's FOBs as fully substitutable, the article confirms that its FOBs should have much greater partnering value than competitive biosimilars (which, of course, is a point that has already been made many times).
http://www.fiercebiotech.com/press-releases/majority-us-and-european-physicians-are-wary-using-biosimilar-indication-wh?utm_medium=nl&utm_source=internal
>>The Majority of U.S. and European Physicians Are Wary of Using a Biosimilar for an Indication for Which Supporting Clinical Data
Tools Email
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Contact Author
Posted August 24, 2011
French Physicians are the Most Conservative When Asked About Indication Extrapolation, According to New Research from Decision Resources
BURLINGTON, Mass.--(BUSINESS WIRE)--Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of U.S. and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking. According to new analysis, physician attitudes about indication extrapolation-where a biosimilar needs only to show similarity in a Phase III study for one indication, and it will be granted approval for other indications for which the branded product is used-vary by country. French physicians are the most conservative when asked about indication extrapolation when compared to German and U.S. physicians.
Analysis from Biosimilars Advisory Service: Acceptance of Biosimilars Across Physician Specialtiesalso finds that surveyed rheumatologists, nephrologists and gastroenterologists in particular say indication extrapolation should not be allowed or should be done carefully because of minute differences between the biosimilar and the branded product that may be clinically significant.
"It's not surprising to see that rheumatologists, nephrologists and gastroenterologists we surveyed are wary of indication extrapolation as these specialists have expressed a moderately conservative approach to biosimilars," said Decision Resources Analyst Edward Wydysh, Ph.D. "To meet physician expectations, biosimilar manufacturers will most likely need to conduct clinical trials in several indications, which may be cost-prohibitive for a smaller company to enter the market. If a biosimilar manufacturer with fewer resources wants to compete with an original biologic in more indications, it should focus on therapeutic areas and drug classes that surveyed physicians find most acceptable for extrapolation, for instance granulocyte colony stimulating factors, or G-CSFs, in oncology."
The Acceptance of Biosimilars Across Physician Specialties module offers extensive primary research to examine physician attitudes towards biosimilars across the United States, France and Germany. It is offered as part of Decision Resources' Biosimilars Advisory Service which provides insight and analysis of the evolving biosimilars market.
Webinar
Members of the media are welcome to attend our upcoming webinar entitled Anticipated Uptake of Biobetters by Physician Specialty: What Do Physicians' Attitudes Toward Biobetters Indicate About Their Likelihood of Using Biosimilars? This webinar will be held on Wednesday, August 31 at 10 a.m. U.S. Eastern Time. For more information, please contact Lisa Osgood at 781-993-2606 or by e-mail at losgood@dresources.com.
About the Biosimilars Advisory Service
The Biosimilars Advisory Service provides insight and analysis that's vital to successful business planning in the rapidly evolving biosimilars space. The service includes quarterly webinars detailing major developments, analyst insight addressing key market changes and opportunities and therapeutic area-specific primary research and forecasting modules.
About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.
About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.
Seems to me that Teva could simply agree to concede its patent infringement claims against any generic Copax which receives FDA approval. This would be pro-competitive and should eliminate the anti-trust concerns.
Copaxone is far more expensive, according to the NYT story on this study. But let's hope generic competition doesn't reduce the expense too much.
Apologies, I should have made my response clearer. I was referring to Amgen's Neulasta patent (5,824,784, link below), which pegylates G-CSF to make it long acting. This patent runs until October 2015. I conducted a quick search for a patent or P/A covereing ratiopharm's pegged version but could not find one.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,824,784.PN.&OS=PN/5,824,784&RS=PN/5,824,784
Teva has 2 Neulasta knock-offs in the works, one of which came with the ratiopharm acquisition. Here's the recent PR on the Phase III trial for XM22:
http://www.tevapharm.com/pr/2011/pr_1018.asp
I doubt Neulasta is covered by the settlement. Amgen's 10K shows the Neulasta US patent as expiring in Oct 2015. The ratiopharm Neulasta biosimilar is not yet on the market, but I recall a recent report from Teva that the PIII trial for the biosimilar was a success.
NKTR 5,000 call bet
Very risky, IMO, if it's on the results from the 110-patient extension trial of NKTR-102 in ovarian by the Feb. expiration date. It took NKTR from the end of ASCO in June 2010, when they announced the extension, until March to recruit the original target of 50 patients. After a Feb. meeting with the FDA, they tacked on 60 more patients, and the most recent 10Q states that they expect the trial to continue recruiting until year end. "Top-line" ORR results are now expected sometime in Q1. My guess would be March, assuming recruitment winds up in December.
A more likely bet, IMO, is that the call buyer is hoping for an announcement of a post-PI deal for NKTR-181, its opioid pain drug, by mid-Feb. NKTR is completing a single-dose trial in 125 patients (interim results, link below, were reported in June) and expects to start and finish a follow-on multi-dose trial by year end. AZN, which has partnered on NKTR's OIC compound, NKTR-118, would be a logical partner for 181, and with its patent cliff issues, might be willinig to make a good deal with a significant upfront. Otherwise, NKTR will probably need to do a fund raise in January or February to have enough cash to satisfy its quarterly cash burn, pay off a $215M convertible coming due in Sept. 2012, and run an 800+ PIII trial of 102 in patients with mBC who have failed ATC, starting in Q4 of this year. NKTR's cash burn rate without the mBC trial is about $30M/Q, which means that the $410M of cash projected to be on hand at year end would likley be exhausted in Q1 of 2013, if the mBC trial is initiated this year as planned.
http://ir.nektar.com/releasedetail.cfm?ReleaseID=583170
I was just about to post this info on Dew's board, but he beat me to it.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=64376023
FWIW, the judge's order denying summary judgment to Teva based on Teva's inequitable conduct also applies to Momenta and Sandoz, whose case has been consolidated with the Mylan case. The judge set a bench trial on the Mylan/Sandoz/Momenta inequitable conduct claim against Teva for July 11.
I lack the photshop skills to import the text of the order, which is all of 2 pages, into this post. The order is available through the US courts PACER system for a slight charge.
estimate for approval of generic fondaparinux ANDA
I am unsure how relevant an AUS broker's analysis of the estimated timeline for approval of Alchemia's generic fondaparinux ANDA is to the timing of approval of generic copaxone, but FWIW here it is:
As a former EMIS investor, I found the SA article a poorly-researched puff piece. It fails to take into account the likelihood that a competing oral calcitonin pill from UGNE/Tarsa will be approved next year for OP. See link below. I am also not sure how much market share a daily pill for OP will take from Reclasta, which will shortly go generic and is administered by IV every 1 to 2 years, or from AMGN's denosumab, which is injected once every 6 months. NVS's old pipeline reports placed primary emphasis on oral calcitonin's potential to treat OA. I doubt NVS is very excited about the OP market. NVS will also owe roylaties to UGNE for its calcitonin manufacturing process (5% royalty a guess), and it has a development deal with Nordic Biosciences, which has been running the PIII calcitonin trials for an undisclosed net profit share. NVS may lack the financial incentives to engage in heavy promotion of calcitonin in the OP market.
The dilution risk is also huge. I believe MHR has the ability to trigger the ratchet in his convertible, the interest and principal on which will exceed $30M when it matures in Sept. 2012, by exercising warrants he received in August 2009. The current conversion price is $3.78/sh, but I think the ratchet will take that price down below $.70/sh, based on the price of the shares and warrants issued to MHR and other investors in the 2009 offering.
Down the road EMIS may be worth considering again as an investment, but I am avoiding it for the foreseeable future.
http://www.unigene.com/content/investors-and-media/press-releases-detail.php?reqid=1542457
I agree on the 1 - 3 year potential and would not welcome a buyout offer at even a 100% premium (which is on the high side). But if NVS is looking for additional expertise in difficult-to-copy generics, biotech drug development potential, and current and relatively near-term added revenue producers, MNTA would seem an attractive target.
MTNA certainly fits the NVS description for a "bolt-on acquisition"
Ccurrent market cap is just under $1B, and NVS already owns 8.1% of MNTA
>>Novartis Eyes Consumer, Veterinary Purchases Up to $3 Billion, Chief Says
By Eva von Schaper - Jun 1, 2011 11:42 AM ET
Novartis AG (NOVN) is willing to spend up to $3 billion on acquisitions of consumer-health or veterinary assets to bolster the drugmaker’s undersized businesses in those areas, Chief Executive Officer Joe Jimenez said.
Novartis also would consider generic-drug, biotechnology or diagnostics purchases, Jimenez said in an interview yesterday at the company’s Basel, Switzerland, headquarters. There’s a dearth of available assets, he said.
“We do expect to make bolt-on acquisitions to these five platforms, and we could do that today,” Jimenez, 51, said. “And when I say bolt-on, I mean anything from $1 billion to $3 billion.” He declined to comment on possible targets or the timing of potential purchases.
**************
Novartis’s Sandoz unit, which makes generic drugs, may benefit from additional acquisitions in the “sweet spot” of so-called differentiated generics, which are difficult-to- manufacture treatments such as injectable cancer drugs or inhalable respiratory products, Jimenez said.
Biotechnology
The Swiss drugmaker, which is Europe’s second-largest after Roche Holding AG, also would be interested in biotechnology companies with some products in development, Jimenez said.
************ <<<<<<<<<
http://www.bloomberg.com/news/2011-06-01/novartis-eyes-consumer-veterinary-purchases-up-to-3-billion-chief-says.html
Seems to me the more consequential trial will be the second P3 Biogen is running, which includes a Copaxone arm:
ALKS release on P2 results for its oral OIC drug.
Appears to be a useful link for the companies covered in the database. Coincidentally (in view of the multiple posts on oral Relistor), there was a link to today's press release from ALKS on its OIC drug. The P2 results have prompted ALKS to announce that it will begin a P3 trial mid-year.
>>Alkermes Announces Positive Preliminary Results from Phase 2 Study of ALKS 37 for Treatment of Opioid-Induced Bowel Dysfunction
- Novel Orally Active Compound Targets Gastrointestinal Tract with Limited Systemic Exposure without Affecting Pain Relief from Opioids -
- Company Intends to Proceed into Pivotal Development Program in Mid Calendar 2011 -
WALTHAM, Mass., Feb 15, 2011 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced positive preliminary results from a phase 2, double-blind, randomized, placebo-controlled clinical study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced bowel dysfunction (OBD), which includes constipation and associated gastrointestinal (GI) abnormalities resulting from chronic use of opioid pain medications. Data from the study showed that ALKS 37 significantly improved GI motility and increased the frequency of bowel movements in patients with OBD, while simultaneously preserving the analgesic effects of opioid treatment. The study also demonstrated that ALKS 37 was generally well tolerated with limited systemic exposure and bioavailability. Based on these results, Alkermes plans to advance ALKS 37 into a pivotal development program in mid calendar 2011.
"OBD is one of the most prevalent side effects of prescription opioid use and a major clinical issue given the widespread utilization of opioids in the treatment of chronic pain," said Anthony Lembo, M.D., Associate Professor of Medicine at Harvard Medical School. "There is significant need for a well tolerated, orally active treatment that enables patients to maintain pain relief without having to experience the debilitating effects of OBD."
In this multi-center, multi-dose study, 87 patients diagnosed with OBD during treatment with opioids for chronic, non-cancer pain were randomized to receive escalating doses of ALKS 37 or placebo pursuant to a pre-defined dose escalation schedule. There was a clear dose-response relationship, with the two highest doses tested (30 mg and 100 mg once daily) demonstrating a statistically significant increase in the pre-specified primary endpoint of change from baseline in the average number of spontaneous bowel movements (SBMs), compared to placebo. Patients receiving 100 mg ALKS 37 once daily had a mean change from baseline in the average number of SBMs per week of 4.6 versus 0.7 in the placebo group (p=0.003), or a net increase of 3.9 SBMs over placebo.
The study also demonstrated a clinically meaningful and statistically significant increase in the average number of complete spontaneous bowel movements (CSBMs) per week from baseline at the 100 mg dose, as compared to placebo. The mean change from baseline in the average number of CSBMs per week for patients receiving 100 mg ALKS 37 was 3.6 versus 0.8 in the placebo group (p=0.006), or a net increase of 2.8 CSBMs over placebo. Importantly, there was no reversal of analgesia as measured by a change in Numerical Pain Rating Scale (NPRS) scores and no increase in opioid use.
"We set out to design a metabolically stable molecule to target the GI tract with limited systemic exposure to address the medically important condition of opioid-induced bowel dysfunction. We have done just that, and are extremely encouraged by the safety, tolerability and efficacy results seen in this phase 2 study of ALKS 37," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "Our goal is to develop an oral drug that can normalize bowel function in patients being treated with opioids for chronic pain, without affecting the analgesic effects of prescription opioid medications. Based on these results, we are looking forward to initiating an aggressive pivotal development program in mid calendar 2011." <<
*************
http://investor.alkermes.com/phoenix.zhtml?c=92211&p=irol-newsArticle&ID=1529016&highlight=
TEVA on the prowl -- CFO interview
Is MNTA prey? The MNTA buyout rumor was posted earlier this week, and one of the TEVA articles posted mentioned the CFO interview, but I do not believe the report below on the most interesting part of his interview has been posted -- that TEVA is looking for more acquisitions (and MNTA would fall within their price range):
Teva Is Ready for Ratiopharm-Sized Deal, Desheh Says
By Naomi Kresge - Wed Feb 09 16:55:00 GMT 2011
Teva Pharmaceutical Industries Ltd. is ready for an acquisition the size of last year’s 3.63 billion-euro ($4.9 billion) Ratiopharm GmbH takeover as it aims to boost sales to $31 billion by 2015.
The Israeli company is weighing opportunities for acquisitions larger and smaller than Ratiopharm, in branded and generic drugs, Chief Financial Officer Eyal Desheh said in a telephone interview. Teva snatched Ratiopharm away from Pfizer Inc. last March, one in a string of deals that have helped it join the ranks of the world’s fastest-growing drugmakers.
“Are we ready for another acquisition the order of magnitude of Ratiopharm? The answer is yes,” Desheh said yesterday. “We are looking at a number of targets.”
Teva, based in Petah Tikva, Israel, is hunting for acquisitions as its best-seller Copaxone may face the double threat of new therapies and generic competition. The company estimates that a combination of its own cash flow and its ability to borrow means it will have almost $30 billion to spend over the next five years.
Teva said in January 2010 it would use less than one-third acquisitions and about two-thirds organic growth to more than double revenue by 2015.
The drugmaker believes it can meet its 2015 target without buying competitors, Desheh said. With cash available to do deals, though, Teva may seek a bigger percentage of growth from acquisitions than executives predicted when it set its long-term targets 13 months ago, he said.
“If I want to be realistic, we’ll probably do more,” he said. “We have more cash. It’s a possibility.”
Teva had about $1.2 billion in cash on hand at the end of December. Desheh declined to comment on where the companies Teva is targeting are located.
German drugmaker Stada Arzneimittel AG fell 8 cents, or 0.3 percent, to close at 28.75 euros in Frankfurt trading. The stock had traded as low as 28.50 euros prior to Desheh’s comments.
To contact the reporter on this story: Naomi Kresge in Frankfurt at nkresge@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
http://www.bloomberg.com/news/2011-02-09/teva-getting-ready-for-ratiopharm-sized-acquisition-finance-chief-says.html
Agreed that traction will be hard earned for Prolia
I recall that Dew has pointed out that Reclast/Zometa will be going generic in the not too distant future, which will likely substantially reduce Prolia's uptake. Note also that the bisphosphonates are demonstrating a cancer prevention benefit from long-term use. Perhaps Prolia will do so as well, but the bisphosphonates have been around for years, making an analysis of long-terms benefits (and risks) an easier task.
For example:
ASCO GI: Bone Drugs Cut CRC Risk
SAN FRANCISCO -- Postmenopausal women taking oral bisphosphonates for osteoporosis had almost a 50% reduction in the risk of colorectal cancer, according to data from a large cohort study.
The case-control study, conducted among over 1,800 Israeli women, found that the magnitude of the risk reduction increased with length of time women were on antiresorptive therapy -- topping out at almost 80% with more than three years of bisphosphonate use, Gad Rennert, MD, of Carmel Medical Center in Haifa, and colleagues reported here at the Gastrointestinal Cancers Symposium...........
**************
http://www.medpagetoday.com/MeetingCoverage/ASCOGI/24492
Big pharma interest in biosimilars (which will obviously enhance MNTA's prospects).
Copying biotech medicine attracts more drugmakers
* Branded makers consider entering biosimilars arena
* Amgen, Biogen exploring biosimilars
* Merck has Neupogen, Neulasta biosimilar trials underway
By Deena Beasley
SAN FRANCISCO, Jan 13 (Reuters) - More drugmakers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as U.S. guidelines take shape.
The topic was at the forefront of plans discussed by several executives at this week's JP Morgan healthcare conference in San Francisco.
**************
http://uk.reuters.com/article/idUKN1313681520110113?rpc=401&feedType=RSS&feedName=governmentFilingsNews
Sandoz a co-plaintiff
Although not mentioned in Momenta's PR, Sandoz is also a plaintiff:
COMPLAINT
INTRODUCTION
Plaintiffs Momenta Pharmaceuticals, Inc. (“Momenta”) and Sandoz Inc. (“Sandoz”),
bring this action for patent infringement and declaratory judgment against defendants Teva
Pharmaceuticals Industries, Ltd and Teva Pharmaceuticals USA, Inc. (collectively, “Teva”).
Plaintiffs seek judgment that certain methods used by the defendants when making an
enoxaparin drug product have infringed and/or will infringe United States Patent Nos. 7,575,886
(the “'886 patent”) and 7,790,466 (the “'466 patent”).
extracts from Momenta complaint
TEVA’S INFRINGING CONDUCT
22. On information and belief, Teva intends to market imminently an enoxaparin
product in the United States. In order to manufacture commercial quantities of generic enoxaparin in preparation for launch, Teva has engaged in, and/or is engaging in, activities that
infringed, or are infringing, the claims of the '886 and '466 patents.
23. In accordance with its announced plans to market a generic enoxaparin product in
the United States, Teva filed an ANDA and amendments thereto with the FDA.
24. Teva has stated that it intends, and is prepared, to sell its enoxaparin immediately
following FDA approval. In February 2010, the President and CEO of Teva North America
Pharmaceuticals, Bill Marth, stated: “[A]ll I can say is that when that approval [of generic
enoxaparin] comes, we’ll be ready.” A true copy of Teva’s Q4 2009 Earnings Conference
Transcript, dated February 16, 2010, is attached hereto as Exhibit C.
25. In May 2010, Teva stated its belief that FDA approval of its enoxaparin product
would occur shortly thereafter. Teva’s President and CEO, Shlomo Yanai, stated: “Again you
know, all the questioning we get from the FDA leads us to be fairly confident that [approval] will
come .... We’re just hopeful that it comes soon as we see the questioning. It just leads us to
believe that it is that we’re far down the path.” A true copy of Teva’s Q1 2010 Earnings Call,
dated May 4, 2010, is attached hereto as Exhibit D.
26. On July 23, 2010, the day that the FDA approved Sandoz and Momenta’s generic
enoxaparin sodium for commercial sale, Teva announced that “[it] believes it has demonstrated
to the FDA that its version of generic Lovenox® meets their criteria and that Teva’s pending
ANDA is approvable.” A true copy of Teva’s press release, dated July 23, 2010, is attached
hereto as Exhibit E. Later, in July 2010, Teva’s Mr. Marth stated: “As far as launch quantities
with respect to enoxaparin, the answer is yes we’re in good shape. So we just will need the
approval ....” A true copy of Teva’s Q2 2010 Earnings Conference Transcript, dated July 27,
2010, is attached hereto as Exhibit F.
27. In August 2010, Teva stated its belief that its enoxaparin product would be
approved by the FDA. Teva’s Research and Development Officer, Benzion Weiner, stated to
Israel’s Calcalist financial newspaper: “We are waiting to receive the approval soon and the
chances of receiving it is high.” A true copy of the article entitled, “Teva Copy of Lovenox®
May Be Close,” Reuters, dated August 5, 2010, is attached hereto as Exhibit G.
28. During an earnings call held on November 2, 2010, Teva’s President and CEO,
Mr. Yanai, reported that during a recent meeting with the FDA “we confirmed that our version of
generic Lovenox® meets the FDA’s criteria to demonstrate chemical sameness.” On the same
call, Teva’s Mr. Marth stated that Teva is “still hopeful” that it will obtain FDA approval this
year. A true copy of Teva’s Q3 2010 Earnings Conference Transcript, dated November 2, 2010,
is attached hereto as Exhibit H.
29. On information and belief, in order for Teva to have had a reasonable basis for its
statements that it believes that the FDA will approve its manufacture of generic enoxaparin, Teva
has included in its manufacturing process for each batch of enoxaparin sodium that it has
prepared, and will prepare, for commercial sale:
(a) a method for determining that its oligosaccharides contain the 1,6-anhydro
derivative. The use of such a method infringes the '886 patent; and
(b) a method for determining the presence, in the tetrasaccharide chains of its
enoxaparin, of particular chain sequences in particular relative amounts
that infringes the '466 patent.
30. On information and belief, in order to be prepared for immediate commercial
launch in the United States, Teva has manufactured and/or is in the process of manufacturing
commercial quantities of generic enoxaparin sodium using the methods claimed in the '886 and
'466 patents.
COUNT I
(Infringement of U.S. Patent No. 7,575,886)
31. Plaintiffs re-allege, and incorporate herein by reference, the allegations of
Paragraph 1-30 of this Complaint as if fully set forth herein.
32. Teva has infringed, and continues to infringe, or has induced others to infringe,
the '886 patent, either literally or under the doctrine of equivalents, by, inter alia, manufacturing
generic enoxaparin for commercial sale using the methods claimed in the '886 patent and
offering those products for sale in the United States.
33. Teva has not obtained a license to use the methods claimed in the '886 patent or to
offer for sale in the United States products made by that process.
34. Unless Teva is preliminarily and permanently enjoined by this Court from
offering to sell, and selling, its generic enoxaparin product made using methods that infringe the
'886 patent, Momenta and Sandoz will be substantially and irreparably harmed by Teva’s
infringing conduct.
35. Upon information and belief, Teva’s direct or indirect infringement of the '886
patent has been, and continues to be, willful, deliberate, and objectively reckless. Teva’s
conduct provides a basis for this Court to award enhanced damages pursuant to 35 U.S.C. § 284,
and makes this an exceptional case within the meaning of 35 U.S.C. § 285.
COUNT II
(Infringement of U.S. Patent No. 7,790,466)
36. Plaintiffs re-allege, and incorporate herein by reference, the allegations of
Paragraph 1-35 of this Complaint as if fully set forth herein.
37. Teva has infringed, and continues to infringe, or has induced others to infringe,
the '466 patent, either literally or under the doctrine of equivalents, by, inter alia, manufacturing
generic enoxaparin for commercial sale using the methods claimed in the '466 patent and
offering those products for sale in the United States.
38. Teva has not obtained a license to use the methods claimed in the '466 patent or to
offer for sale in the United States products made by that process.
39. Unless Teva is preliminarily and permanently enjoined by this Court from
offering to sell, and selling, its generic enoxaparin product made using methods that infringe the
'466 patent, Momenta and Sandoz will be substantially and irreparably harmed by Teva’s
infringing conduct.
40. Upon information and belief, Teva’s direct or indirect infringement of the '466
patent has been, and continues to be, willful, deliberate, and objectively reckless. Teva’s
conduct provides a basis for this Court to award enhanced damages pursuant to 35 U.S.C. § 284
and makes this an exceptional case within the meaning of 35 U.S.C. § 285.
*****************
PRAYER FOR RELIEF
WHEREFORE, the plaintiffs respectfully request:
(a) That the Court determine that Teva has infringed, is infringing, or will
infringe, one or more claims of United States Patent No. 7,575,886;
(b) That the Court determine that Teva has infringed, is infringing, or will
infringe, one or more claims of United States Patent No. 7,790,466;
(c) That the Court enter a preliminary injunction restraining Teva, its officers,
agents, attorneys, servants, employees, and all persons in active concert or
participation with them, from selling, offering to sell, or importing into the
United States an enoxaparin product made using a method that infringes
one or more claims of either United States Patent No. 7,575,886 or U.S.
Patent No. 7,790,466;
(d) That the Court enter a permanent injunction precluding Teva, its officers,
agents, attorneys, servants, employees, and all persons in active concert or
participation with them, from selling, offering to sell, or importing into the
United States an enoxaparin product made using a method that infringes
one or more claims of either United States Patent No. 7,575,886 or U.S.
Patent No. 7,790,466;
(e) That the Court determine the amount of damage caused to Momenta and
Sandoz by Teva’s infringing conduct and enter judgment for Momenta and
Sandoz in the amount of their damages, plus interest and the costs of this
action;
(f) That the Court determine that Teva’s infringement has been willful and
deliberate and award up to treble damages to Momenta and Sandoz
pursuant to 35 U.S.C. § 284;
(g) That the Court determine that this case is exceptional, within the meaning
of 35 U.S.C. § 285, and order Teva to pay plaintiffs’ reasonable attorneys’
fees pursuant to 35 U.S.C. § 285; and
(h) That the Court grant such other and further relief as it deems appropriate.
In the very small 1-year study reported at the link below, Lucentis and Avastin had a similar therapuetic benefit, but Lucentis required fewer injections. I recall that when Lucentis was approved, Genentech touted the shorter half life of Lucentis as an advantage Lucentis held over Avastin. You would think, however, that a shorter half life would mean more, rather than fewer, injections. The link gives some possible explanations for this result. The NEI trial data should be interesting.
http://irvaronsjournal.blogspot.com/2010/10/avastinlucentis-update-42-one-year.html
Isn't a filing for European approval of m-enox a potential (if not pobable) news item for 2011, given CW's remarks during the 3Q call:
link to Teva 3Q earnings call transcript from S/A
http://seekingalpha.com/article/234179-teva-pharmaceutical-industries-ceo-discusses-q3-2010-results-earnings-call-transcript
Obamacare tax incentives
I believe it's the IRS that administers the Obamacare tax grant/credit program. So the following selection should come as no surprise:
MNTA 3Q earnings call transcript now available at Seeking Alpha
http://seekingalpha.com/article/233912-momenta-ceo-discusses-q3-2010-results-earnings-call-transcript
One of my mottos in small biotech investing is to avoid companies that are likely to dilute (or as the Countours and J. Geils put it, "First I look at the purse.") I doubt we will ever have this worry again with MNTA, but I found the following statement from CW reassuring:
Here are the quotes I am basing my 1.7 months and significance of the trial on
Thanks for the your and DD's responses and your link. As should be clear from my post, my knowledge of statistics leaves a lot to be desired.
>>increase PFS by exactly 1.7 months<<
According to the ESMO abstract,the trial's primary endpoint was a 28%/5-month improvement in PFS, but it concludes by stating that the addition of Avastin improves PFS, without giving out the PFS number. Was it just 1.7 months? I would have assumed the 5-month endpoint was hit.
>>Hepatitis C drug fights virus in new way << update on Santaris drug
Santaris Pharma A/S advances miravirsen, the first microRNA-targeted drug to enter clinical trials, into Phase 2 to treat patients infected with Hepatitis C virus
Hoersholm, Denmark/San Diego, California, September 22, 2010 — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naïve patients infected with the Hepatitis C virus (HCV).
Paving the way to conduct the first clinical trials of a microRNA-targeted drug in the United States, Santaris Pharma A/S also received acceptance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). In addition to the United States, the Phase 2a clinical trials will be conducted in the Netherlands, Germany, Poland, Romania, and Slovakia.
The World Health Organization estimates about 3% of the world’s population has been infected with HCV and that some 170 million are chronic carriers at risk of developing liver cirrhosis and/or liver cancer2. Approximately 3-4 million Americans are chronically infected with an estimated 40,000 new infections per year1. In Europe, there are about 4 million carriers2. The current standard of care, pegylated interferon in combination with ribavirin, is effective in only about 50% of those treated1.
Developed using Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform, miravirsen is a specific inhibitor of miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication. Miravirsen is designed to recognize and sequester miR-122, making it unavailable to the Hepatitis C virus. As a result, the replication of the virus is effectively inhibited and the level of Hepatitis C virus is reduced.
*******************
http://www.santaris.com/Library/documents/miravirsenPhase2clinicaltrials.pdf
>>I assume that SNY launches an AG<<
If SNY comes out with an AG in the US, can an EU member seek to compel SNY to sell the AG in that country? Since the AG is Lovenox, the clinical trials required to show comparable efficacy and safety (see FDA extract below) for EMA approval would not seem necessary. Even if sale cannot be compelled, is it not likely that the Europeans would negotiate for Lovenox price cuts based on the US AG price? Obviously, if non-US Lovenox sales/pricing would be placed in jeopardy by an AG, the chances of an AG should go down substantially, perhaps even in a multiple generic scenario (at least until competitors obtain EMEA approvals).
From FDA Q&As on generic enoxaparin:
>>Good ruling.<< I agree. I thought it highly unlikely that the judge would grant a PI, but you never can be absolutely certain with litigation. After reading the opinion and the court's rationale about the great deference to be given agency determinations in their area of expertise, I find it inconceivable that sanofi will prevail on the merits.
Here's a link to the opinion. I have not yet read it.
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2010cv1255-27
EMIS/NVS’ oral calcitonin bombs in phase-3
As I was driving to my office yesterday morning, I was mentally reviewing my stock holdings (including EMIS) and the thought struck me, at random, that today would be a good day for the FDA to approve MNTA's generic lovenox. My next thought was - no way, why would the FDA choose a hot summer Friday in July to do so - and went back to considering whether I could complete the sale of the rest of my shares in EMIS. The previous friday, post-close, EMIS issued a press release suggesting that another financing was a strong possibility. For me this was the last straw - another dilutive financing sure to trigger ratchets in a convertible note and warrants held by EMIS's largest shareholder - and I resolved to liquidate my remaining shares over the next week. I succeeded in selling 70% of the shares Mon. - Wed. but none on Thur. when total share volume was only 4,500.
Arrived at the office, and the first new email to hit my inbox was the calcitonin press release from EMIS which you linked to. I was completely out of EMIS shortly after the market opened. Around 11, my wife called me to ask me where we were going for our big celebration tonight. Since she holds (still) a few thousand EMIS shares (which I had advised her to sell), I thought she was being facetious, but she she sounded in remarkably good spirits. When I questioned her further, she responded that I had obviously not seen the MNTA press release and trading halt.
Needless to say, we had a excellent celebration last night
Thanks Dew for the great info and insight you have provided on MNTA over the years. My wife thanks you as well as she owns even more MNTA shares than I do.
Tekmira Awarded Up to $140 Million U.S. Government Contract to Develop RNAi Therapeutic Against Ebola Virus
Thanks for replying to DD's question on Haussecker. I have been following his commentary for about a year, and he seems quite knowledgeable about RNAi companies and the potential merits of their technologies. I have yet to invest in an RNAi company but maybe down the road. Today's TKM news hardly seems worth a one-day trading halt. My guess is that it resulted from a failure by DoD and TKM to coordinate on the timing of the release.
http://finance.yahoo.com/news/Tekmira-Awarded-Up-to-140-ccn-1558440061.html?x=0&.v=1
VANCOUVER, BRITISH COLUMBIA--(Marketwire - July 15, 2010) - Tekmira Pharmaceuticals Corporation (TSX:TKM - News), a leader in RNA interference (RNAi) therapeutics, today announced that it has been awarded a new contract with the United States Department of Defense (DoD) Chemical and Biological Defense Program (CBDP) through the U.S. Army Space and Missile Defense Command (SMDC), to advance an RNAi therapeutic utilizing Tekmira's lipid nanoparticle technology, SNALP (stable nucleic acid-lipid particle), to treat Ebola virus infection, which is lethal to humans. More than 15% of the estimated value of this award will be subcontracted to U.S. businesses. Tekmira has a U.S. affiliated office based in Washington state, Protiva USA.
In the initial phase of the contract, which is funded as part of the Transformational Medical Technologies (TMT) program, Tekmira is eligible to receive up to U.S. $34.7 million over the next three years. This initial funding is for the development of an Ebola SNALP product candidate through pre-clinical development, filing of an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA), and completion of a Phase 1 human safety clinical trial.
Additionally, TMT has the option of extending the contract beyond the initial funding period to support the advancement of the Ebola SNALP product through clinical development and FDA approval. Based on the contract budget, this would provide Tekmira with a total of up to U.S. $140 million in funding for the entire program.
Dr. Mark J. Murray, Tekmira's President and CEO, said, "This contract is a significant accomplishment for Tekmira and a proud moment for our team. It is important recognition of the potential of our SNALP platform and, more broadly, the promise of RNAi to treat serious infectious diseases such as Ebola. We are enthusiastic about advancing Ebola SNALP through clinical trials to FDA approval. This work builds on our recently published research, where we reported that Ebola SNALP could confer complete protection to non-human primates from a lethal dose of Ebola virus."
In May, Tekmira working in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), published data in The Lancet (Geisbert et al., "Post exposure protection of non-human primates against a lethal Ebola virus challenge with RNA interference: a proof of concept study", The Lancet, Vol 375, May 29, 2010) describing the antiviral activity of small interfering RNA (siRNA) in SNALP targeting the Ebola virus (Ebola SNALP). When used to treat previously infected non-human primates, Ebola SNALP resulted in 100% protection from an otherwise lethal dose of Zaire Ebola virus.
For many years, the Zaire species of Ebola virus (ZEBOV) has been associated with periodic outbreaks of hemorrhagic fever in human populations with mortality rates reaching 90%. There are currently no treatments for Ebola or other hemorrhagic fever viruses.
Tekmira believes its SNALP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira's SNALP platform is being utilized in multiple preclinical and clinical trials by both Tekmira and its partners.
*******
Tekmira Halted
FWIW, 2 weeks ago Dirk Haussecker speculated that Tekmira was a logical target for NVS (which releases quarterly earnings tomorrow):
http://rnaitherapeutics.blogspot.com/
Tuesday, June 29, 2010 Upcoming $100M Novartis Decision to Shake Up RNAi Therapeutics
As critical court rulings that could decide who will control the fundamental Tuschl patents are getting delayed at least into September, probably later than that (see the ‘RNAi litigation’ blog for the latest updates), the $100M question of whether Novartis will exercise their right to broadly adopt Alnylam’s fundamental RNAi trigger IP estate is likely to replace the RNAi litigation as the driving force in the RNAi Therapeutics deal dynamics in the near future.
Under the 2005 research collaboration and license agreement, Novartis paid Alnylam $10M in upfront cash in addition to a $58.5M equity investment in Alnylam's stock for the right to (exclusively) pick 30 therapeutic gene targets protected under Alnylam’s fundamental RNAi trigger IP as part of the research collaboration, and for the right of first offer to additional targets that Alnylam develops and wishes to partner. As I understand it, Novartis has until the end of the term of the research collaboration, probably October 12 2010, to pick their targets, and retains the right of first offer until 3 years thereafter (hold your breath if you expect new product-specific partnering before that).
In addition, Novartis also obtained the option to broadly adopt Alnylam’s fundamental RNAi trigger estate exercisable for an additional $100M. This non-exclusive license has been characterized by Alnylam to work similar to Alnylam’s platform relationships with Roche and Takeda. These licensing relationships provide the companies non-exclusive access to Alnylam’s fundamental RNAi trigger IP that will provide coverage until 2016-2025. One important difference, however, is that Novartis could use this IP in all therapeutic areas, not just a few select ones as in Takeda's and Roche's case. The other important difference, which I believe has the potential to fundamentally change the competitive landscape in RNAi Therapeutics, is that, unlike Roche and Takeda, the licenses do not provide Novartis access to crucial RNAi delivery technologies. Novartis has until the end of the research collaboration (October 2010) to decide on the option and think long and hard about their delivery strategy.
It would seem quite logical for Novartis to exercise the option. For one, Novartis is certainly ramping up their RNAi Therapeutics efforts based on the flurry of related job advertisements. Moreover, $100M would appear to be quite a bargain for such broad freedom to pick gene targets compared to what Takeda and Roche got. In fact, it would make Novartis the company with the most power in RNAi target picking. Lastly, Novartis has been consistently buying Alnylam shares in recent years to maintain their ownership at 13.4%. Such purchases have to be considered strategic.
But as I said, all this target selection power may not be worth that much without delivery. In fact, a long delay for Novartis in gaining access to say delivery to the liver and cancers (I’d love to have some insight into the targets that Novartis has picked thus far, but hepatitis C is a likely one and quite a few cancer-related targets, too), may quickly diminish the value of their initial 30 exclusive target picks as the patent clock is running down. So at some point Novartis has to think about entering the clinic and learn about the clinical aspects of RNAi Therapeutics development.
There are not that many delivery technologies that can provide clinically relevant delivery of synthetic siRNAs. As you will know, I consider SNALP technology as the most advanced at the moment. I would therefore expect Novartis to try and gain access to it. Last year, Novartis paid mdRNA roughly $7M basically to take a look at that company’s liposomal siRNA delivery technology. One way to interpret this was that Novartis wanted to evaluate (cheaper) alternatives to having to go through Alnylam and/or Tekmira in gaining access to liposomal siRNA delivery. One thing is for sure, Alnylam would likely make Novartis pay extra for a sub-license to SNALP-related Semple/Wheeler. Alternatively, Novartis may not like Alnylam’s terms and gain access to SNALP by buying Tekmira. What makes this even more attractive is that it would on top provide Novartis with another 7 target picks, which it could pick also after October 2010, and critical expertise on the use of SNALP. This is important because even if Alnylam gave Novartis access to the SNALP-related Semple/Wheeler IP, it, like Takeda and Roche before it, would still very likely require the co-operation of Tekmira to fully exploit SNALP technology. Such expertise would, of course, also benefit the overall RNAi delivery effort of Novartis.
With 37 targets protected by Alnylam’s RNAi trigger IP (note: the exact number would depend on how many targets Novartis will have chosen by October), one has got to wonder whether just buying Tekmira for $200M may be the better deal. 37 targets should be more than enough to keep them occupied into the early 2020’s. Or if Novartis was feeling real lucky and would like to become the dominant force in RNAi Therapeutics, it would spend $300M for the adoption license and Tekmira and look quite smart in comparison to Merck, Roche, and Takeda.
The above scenarios should, of course, give other Big Pharma companies cause for concern. Assuming for example that Pfizer agrees SNALP to be the most promising systemic RNAi delivery technology, it may not like the prospect of another important RNAi delivery technology disappearing from the market, just as it happened to them in 2008 when Roche bought Mirus Bio with which Pfizer had a siRNA delivery collaboration then.
Of course, if events unfolded like this, all other pure-play RNAi Therapeutics companies should also benefit. Alnylam Pharmaceuticals, mainly because it would confirm the interest by Big Pharma in RNAi Therapeutics, and pure-play companies like Silence Therapeutics, mdRNA, and RXi, because they would be viewed as moving up the acquisition queue.
PS: The above scenarios are based on a few assumptions, the most important of which probably being that an acquisition of Tekmira would also transfer the right to exploit SNALP technology for Tekmira’s 7 target picks (which are transferable) in the case of a Big Pharma which otherwise has not gained access to Alnylam IP, and in the case of Novartis, possibly for all its other target picks, too.
Posted by Dirk Haussecker at Tuesday, June 29, 2010
Labels: Alnylam, Novartis, Pfizer, SNALP, Tekmira