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You beat me to the punch. Actually from what i can remember shire withdrew the FDA application and was planning to resubmit data. I can't remember them submitting data after that.
GSK got better revenue sharing terms than Shire did.
Is there such a market as obese males who are not at risk for cardiovascular events? If there is maybe VVUS can hope and pray for that label if they can't convince the FDA to approve the drug for a broader label.
Minister confirms NICE will be sidelined in drug evaluation
Published on 26/10/10 at 09:29am
A health minister has confirmed NICE will be “moved” from its current central role in health technology assessment to make way for value-based pricing of medicines.
In the sentences that follow what you quoted, ARNA appears to indicate that a lot depends on how the tumor data is explained away. My guess is that even if ARNA can explain the tumor data and bloom-dm data shows substantial efficacy, the FDA will limit the usage of the drug to people with type II diabetes. If the bloom-dm data shows substantial efficacy and if the cancer data can't be explained, meaning the FDA is unconvinced that long term use of lorquess doesn't lead to cancer, maybe the FDA will still approve the drug with a very restrictive label. IMO if the bloom-dm data shows marginal efficacy lorquess is dead, irrespective of whether ARNA can explain the tumor data, because its a long term use drug and the marginal efficacy is not worth the risk.
Actually i went back and read the partnership PR and it doesn't look like Eisai is obligated to pay for additional clinical trials. So they may just hang around until there is more clarity.
Looks like a lot of lipstick was applied to this PR. Even with bloom-dm as the red text in the pr indicates, a potential approval could only be for obese diabetic people. then ARNA has to prove there is no cancer risk and what's it going to take for that. The only positive i can see is that eisai appears to be standing behind the drug which is surprising, to me at least.
Biotech Omeros gets $20M Vulcan investment, $5M state grant
Seattle Times business staff Seattle biotechnology company Omeros plans to announce Monday a $20 million investment from Paul Allen's Vulcan...
Seattle Times business staff
Seattle biotechnology company Omeros plans to announce Monday a $20 million investment from Paul Allen's Vulcan Capital and a $5 million grant from a state biotechnology-research fund.
The financing will help Omeros advance its research on what are known as G protein-coupled receptors (GPCRs) — a key family of proteins that guides cells' responses to nearby molecules and forms the basis for many modern pharmaceuticals.
Omeros says it uses a proprietary high-throughput system to identify small molecules that can activate or disable GPCRs, unlocking them to drug development.
If the program generates revenues that exceed its research and development and commercialization costs — a rare thing in biotechnology — Vulcan and the state's Life Sciences Discovery Fund would get a percentage "in the midteens" on the first $1.5 billion of net proceeds, the company said. Vulcan also receives five-year warrants to purchase 400,000 shares of Omeros common stock at prices between $20 and $40 per share.
Omeros also said it will pay about $10.6 million in cash and stock to acquire GPCR-assessment technology from Patobios Limited, a Canadian company.
However, there is no pressing reason to approve Bydureon immediately.
I think the once weekly is a big advantage in terms of cost when compared to the other two drugs, given the info below about diabetes patients in the US. Victoza also has a black box cancer warning so there will be patients leery about taking it.
Diabetes to double or triple in U.S. by 2050: government
WASHINGTON | Fri Oct 22, 2010 7:48am EDT (Reuters Life!) - Up to a third of U.S. adults could have diabetes by 2050 if Americans continue to gain weight and avoid exercise, the Centers for Disease Control and Prevention projected on Friday.
The numbers are certain to go up as the population gets older, but they will accelerate even more unless Americans change their behavior, the CDC said.
"We project that, over the next 40 years, the prevalence of total diabetes (diagnosed and undiagnosed) in the United States will increase from its current level of about one in 10 adults to between one in five and one in three adults in 2050," the CDC's James Boyle and colleagues wrote in their report.
"These are alarming numbers that show how critical it is to change the course of type-2 diabetes," CDC diabetes expert Ann Albright said in a statement.
"Successful programs to improve lifestyle choices on healthy eating and physical activity must be made more widely available because the stakes are too high and the personal toll too devastating to fail."
The CDC says about 24 million U.S. adults have diabetes now, most of them type-2 diabetes linked strongly with poor diet and lack of exercise.
Boyle's team took census numbers and data on current diabetes cases to make models projecting a trend. No matter what, diabetes will become more common, they said.
"These projected increases are largely attributable to the aging of the U.S. population, increasing numbers of members of higher-risk minority groups in the population, and people with diabetes living longer," they wrote.
Diabetes was the seventh-leading cause of death in the United States in 2007, and is the leading cause of new cases of blindness among adults under age 75, as well as kidney failure, and leg and foot amputations not caused by injury.
"Diabetes, costing the United States more than $174 billion per year in 2007, is expected to take an increasingly large financial toll in subsequent years," Boyle's team wrote.
What is the current largest selling generic of all time?
I think the only potential concern for MNTA from these impressive numbers is whether SNY is concerned enough about m-enox capturing too large of a market that it has to launch an authorized generic.
MacroGenics and Lilly Announce Pivotal Clinical Trial of Teplizumab Did Not Meet Primary Efficacy Endpoint
Press Release Source: Eli Lilly and Company On Wednesday October 20, 2010, 7:00 pm EDT
ROCKVILLE, Md. and INDIANAPOLIS, Oct. 20 /PRNewswire-FirstCall/ -- MacroGenics, Inc. and Eli Lilly and Company (NYSE:LLY - News) today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.
The DMC concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. The DMC, noting that all administration of experimental drug had been completed, commented that appropriate safety monitoring is warranted. No unanticipated safety issues were identified in the DMC's review.
"We will comply with the DMC's recommendations," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer, MacroGenics. "We remain committed to discovering and developing novel biologics for the treatment of autoimmune disorders like type 1 diabetes."
Following careful evaluation of the DMC's recommendations for Protege, based on the lack of efficacy, the companies have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes: the Protege Encore Trial, a second Phase 3 trial of the same design as Protege, and the SUBCUE trial, a Phase 1b trial that is exploring the subcutaneous administration in patients with type 1 diabetes.
"The failure to meet the primary endpoint is obviously disappointing for the millions of people who live with and treat type 1 diabetes," said Gwen Krivi, Vice President, Product Development, Lilly Diabetes. "Lilly and MacroGenics will be considering all options for teplizumab in type 1 diabetes as well as the impact of the DMC's recommendations on other potential indications."
About Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Insulin is a hormone that is needed to convert sugar (glucose), starches and other food into energy needed for daily life. People with type 1 diabetes must take multiple injections of insulin daily or continually infuse insulin through a pump to manage their blood glucose levels.
Type 1 diabetes, previously known as juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. Of the nearly 24 million Americans who have diabetes, as many as 3 million may have type 1.(i)
About Teplizumab
Teplizumab, also called MGA031 and hOKT3?1 (Ala-Ala), is a humanized, anti-CD3 monoclonal antibody. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases. Specifically, teplizumab may inhibit unwanted effector T cells and enhance beneficial regulatory T cell functions, thus promoting immune tolerance.
About MacroGenics
MacroGenics is a private, venture-backed biotechnology company that focuses on the discovery, development and delivery to patients of novel biologics for autoimmune disorders, cancer and infectious diseases. Since its founding in 2000, the company has built a fully-integrated set of capabilities in monoclonal antibody product development. The company's product development efforts leverage three proprietary technology platforms: (1) cancer stem-like cells; (2) DART, which allows the company to incorporate multiple specificities within a single molecule; and (3) Fc optimization, which enhances antibody-dependent effector functions. These powerful sets of capabilities and technology platforms have enabled MacroGenics to build a proprietary pipeline of innovative product candidates. For more information about MacroGenics, please visit www.macrogenics.com.
FDA: Include warnings on risk for class of prostate cancer drugs
The U.S. Food and Drug Administration today asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer.
The warnings would alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications.
In May, the FDA said that a preliminary and ongoing analysis found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. The new labels will include updates in the Warnings and Precautions section about these potential risks.
Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. This year an estimated 217,730 new cases of prostate cancer will be diagnosed and about 32,050 men will die from the disease, according to the Centers for Disease Control National Center for Health Statistics and the National Cancer Institute.
GnRH agonists are drugs that suppress the production of testosterone, a hormone involved in the growth of prostate cancer. This type of treatment is called androgen deprivation therapy, or ADT. Suppressing testosterone has been shown to shrink or slow the growth of prostate cancer.
GnRH agnoists are marketed under the brand names: Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. Several generic products are available.
Interesting. Most of the points are pretty good though the CRL in March, which mainly listed labeling issues, made the requests in the more recent CRL somewhat unlikely. I'm guessing this particular short felt that AMLN was already priced for approval or at least close to it so going short wasn't as risky. I think the last point about the ads was probably the best, assuming he is right. Does anyone with more insight know about this? Do biotech companies normally place teaser ads in medical journals before approval?
UnitedHealth Alters Pay Rules for Doctors as Cancer Drugs Top $20 Billion By Alex Nussbaum - Oct 20, 2010 9:42 AM ET
UnitedHealth Group Inc., the biggest U.S. health insurer by sales, will pay cancer doctors to stop marking up the prices of drugs, in a test aimed at reducing costs for medical plans and their customers.
Physicians serving 1,500 cancer patients in Georgia, Missouri, Ohio, Tennessee and Texas will receive reimbursement for the wholesale cost of medicine they administer, plus a fee that will stay the same regardless of the drugs involved, UnitedHealth said today in a statement.
That will erase an economic incentive for doctors to prescribe more-costly drugs, as physicians now buy the medicines from drugmakers and charge as much as 30 percent more when submitting claims to insurers, said Lee Newcomer, UnitedHealth’s senior vice president for oncology for UnitedHealth, based in Minnetonka, Minnesota. Cancer drugs account for 60 percent of income for oncologists, Newcomer said.
The tummy tube that fools you into thinking you're full By SOPHIE BORLAND Last updated at 8:32 AM on 15th October 2010
A PLASTIC sleeve that lines the gut to combat obesity and diabetes could soon be available on the NHS. The 2ft-long device, which can be inserted without an operation, has been shown to help the obese lose a fifth of their body weight. It may even stop the need for daily medication or insulin injections for people with Type 2 diabetes.
Doctors say the device, which costs £2,000, could soon be used in hospitals to replace far costlier gastric bands and gastric bypass operations. It can be inserted via the mouth in only 15 minutes, and is far less risky than standard obesity surgery. Doctors are testing the sleeves in three British hospitals in the hope that they will soon be routinely available on the NHS. The device, known as an Endobarrier, lines the duodenum – a long, thin part of the gut between the stomach and the small intestine. It is held in place by a tiny spring and acts as a barrier to stop fats, sugar and salts being absorbed by the intestine, restricting the amount of calories being absorbed. It also tricks people into feeling full by causing large amounts of undigested food to reach the small intestine, which results in an increase of a hormone called PYY which suppresses the appetite. The sleeve, which stays in the body for six to 12 months, improves Type 2 diabetes by causing the gut to release a hormone called GLP1, which increases the body’s use of insulin and lowers blood sugar levels. Alberic Feines, a consultant bariatric surgeon at St Anthony’s Hospital in Surrey, said: ‘Many patients may not want gastric bypass or band surgery because they don’t want the operation. This procedure would be far preferable.’
I assume you are referring to the 1st line trial where ogx-011+tax showed a 6 month improvement over tax alone. I don't believe they ran a similar controlled trial for 2nd line. If I remember correctly the 2nd line PII trial they ran had 011+tax in one arm and 011+another chemo in the other. Since the 011 trial was in 1st line its difficult to compare the outcome of that trial with that of the abiraterone trial.
Patients not treated with taxotere were excluded from the abiraterone trial. So i'm not entirely sure ogxi is up because the data wasn't good though that could be.
Sorry I meant strictly 2nd line. It would be interesting to compare how sick the patient population was for both trials. From a treatment point of view I imagine only a really sick patient who had undergone more than one chemo treatment would have been given placebo+prednisone.
Actually there could be a slight difference in the patient population for the two drugs. The abiraterone population included patients treated twice with chemo which means there probably were patients already treated with docetaxel and then mitoxantrone. In the cabazitaxel study patients who had previously received mitoxantrone were excluded so i imagine the patient population was strictly 1st line and less sick than the patients in the abiraterone study.
I think its holding up well since jazz already has marketed products which are making sufficient money. There was also a rumor of a buyout a few days back.
I just find it hard to believe there would have ever been a ton of upside if CYPB had resorted to being strictly a play on Savella royalties along with perhaps the option of taking on smaller efforts.
Interestingly, Ramius believes exactly the opposite, and that belief is the reason the share price is where it is now instead of the low 2's.
itmn - Here;s more color on that topic for reference
Well, Terence, we have filed a redacted version of our contract with Roche in our 2006 10-K filed in April or so of 2007. I will direct you to sections of the contract that are appropriate to exclusivity. But as you will see if you read that, you will find that we have an exclusivity to each other for the mechanism of action that is protease inhibition. And there are consequences, should that exclusivity be broken. And so, I would encourage you to look at the disclosure. And we feel very confident and very comfortable in our position that Roche is committed to 191 and has an exclusivity agreement with pretty important consequences to them, should that agreement be broken.
Next weeks FDA decision on JAZZ's jzp-6 could be an interesting event for cypb. Chances are JAZZ will receive a CRL and CYPB could get a small bump out of that.
America today also has its own multibillion-dollar, 25-year-horizon, game-changing moon shot: fixing Afghanistan.
Count the afghan war as china's 5th moon shot
Look at Afghanistan, for example, where American troops have been fighting for nearly a decade, where billions of dollars of American aid money has been spent -- and where a Chinese company has won the rights to exploit one of the world's largest copper deposits. Though American troops don't protect the miners directly, Afghan troops, trained and armed by Americans, do. And though the mine is still in its early phases, the Chinese businessmen and engineers -- wearing civilian clothes, offering jobs -- are already more popular with the locals than the U.S. troops, who carry guns and talk security. The Chinese paid a high price for their copper mining rights and took a huge risk. But if it pays off, our war against the Taliban might someday be remembered as the war that paved the way for Chinese domination of Afghanistan.
Boehringer Ends Female Desire Drug Development After FDA's Safety Query By Naomi Kresge - Oct 8, 2010 3:55 AM ET Tweet LinkedIn Share Print Email Oct. 8 (Bloomberg) - Boehringer Ingelheim GmbH abandoned development of its female desire drug flibanserin after U.S. regulators said the pill wasn’t proven to be safe and effective.
actelion - Amid Sale Queries, Biotech Weighs Next Move OCTOBER 8, 2010 By ANUPREETA DAS And DANA CIMILLUCA
Swiss biotechnology company Actelion Ltd. has formed a special committee of board members to evaluate strategic alternatives for the company, including a potential sale, people familiar with the matter said Thursday.
The special committee, which has hired a financial adviser, is also likely to take up informal takeover approaches the company has recently received from several large pharmaceutical companies, the people said.
Bristol-Myers Squibb Co., Roche Holding AG, GlaxoSmithKline PLC and Amgen Inc. could be in the mix of potential buyers, the people added, but it is unclear if any of them has approached Actelion.
View Full Image
Reuters ACEO Jean-Paul Clozel, above. has preferred independence for Actelion.
A deal is far from certain, especially as Actelion Chief Executive Jean-Paul Clozel has stressed his preference for the company to remain independent, the people said. It is also possible that any deal would fall short of a takeover and instead involve some form of strategic partnership such as a licensing agreement.
The company has a market capitalization of $5.5 billion.
All the companies declined to comment or couldn'timmediately be reached for comment.
Actelion's drugs have recently been beset by a number of problems that have hurt the company's share price. Last month, its experimental drug clazosentan, which is used to treat hemorrhages, failed a late-stage trial. The failure makes it unlikely that the drug, which analysts estimate could have brought in at least $500 million in annual sales, will make it to market soon.
Founded in 1997, Actelion has developed several biotech drugs, including its flagship Tracleer, which is used to treat pulmonary arterial hypertension, a chronic and life-threatening disease. It also makes a drug for type 1 Gaucher disease, a genetic disorder, and has a world-wide alliance with Merck & Co. to make and sell drugs for cardio-renal diseases.
The company is trying to broaden its portfolio of drugs and reduce its dependence on Tracleer sales.
It is also trying to widen the uses of Tracleer. But earlier this year, a study found that Tracleer failed to reduce mortality rates in patients suffering from idiopathic pulmonary fibrosis, a fatal lung condition.
Then, on Sept. 14, the U.S. Food and Drug Administration sent Actelion a warning letter saying that the company's U.S. subsidiary had failed to report about 3,500 deaths in patients using Tracleer and Ventavis, another pulmonary arterial hypertension drug. The agency doesn't blame the drugs for the deaths.
Larger drug makers have been on the prowl for acquisitions because their own laboratories have failed to produce new drugs that can replace the sales of their aging blockbusters. Big pharmaceutical companies have been particularly interested in biotechnology companies like Actelion, whose drugs are either already on the market or nearing approval and can therefore quickly generate revenue.
As Big Pharma's patent cliff has gotten closer, pharmaceutical giants have been buying up mature biotechs. Since 2006, there have been 14 sizeable deals valued at $111 billion.
In Switzerland, Actelion shares gained 5% Thursday on market rumors that potential suitors for the company, including Bristol-Myers, are circling.
China Demand to Help Increase Global Drug Sales to $880 Billion, IMS Says By Ellen Gibson - Oct 6, 2010 7:21 PM ET Tweet (11) LinkedIn Share Print Email Global pharmaceutical sales may rise 5 percent to 7 percent next year to $880 billion, on soaring demand in developing nations led by China as it becomes the world’s third largest drug market, according to IMS Health Inc.
The 2011 projection compares with this year’s 4 percent to 5 percent growth in drug sales to $840 billion, the Norwalk, Connecticut-based research company said in a report released today. Emerging markets including China and India are expected to expand by as much as 17 percent to $180 billion while growth in the U.S. market slows.
The world’s largest market, the U.S., is growing at a historically low rate of 3 percent to 4 percent as patents expire on top-selling medicines and cheaper generic versions become available to consumers, said Murray Aitken, senior vice president of IMS, in a telephone interview yesterday. Drugs with sales of more than $30 billion are expected to lose patent protection next year, according to IMS.
“While the overall market will appear to rebound somewhat in 2011, the underlying constraints to growth in developed markets are stronger than ever,” Aitken said. “Almost half of the global growth next year will come from China and the other emerging markets.”
The five biggest European markets -- Germany, France, Italy, Spain and the U.K. -- will grow 1 percent to 3 percent as governments cut drug prices as part of efforts to restore fiscal balance, according to the IMS report. In the U.S., health plans will require pre-authorization for certain medications along with other measures intended to address rising health-care expenditures.
Generic Competition
Generic copies will hit the market next year for Pfizer Inc.’s cholesterol pill Lipitor, the world’s top-selling drug with sales of $11.4 billion in 2009. Generic versions of the No. 2 seller, Bristol-Myers Squibb Co.’s blood thinner Plavix, will become available in the U.S. in 2012. Together with Eli Lilly & Co.’s antipsychotic Zyprexa and Johnson & Johnson’s antibiotic Levaquin -- also expected to lose market exclusivity -- the drugs account for 93 million prescriptions a year, IMS said.
Developing countries are expected to pick up the slack for those lost revenue. IMS said it expects drug spending in China to increase at least 25 percent next year as the middle class expands and the government invests in health care. Japan is the second-biggest pharmaceutical market after the U.S.
Another bright spot for the industry is the anticipated introduction of several new treatments for diseases including melanoma, hepatitis C and multiple sclerosis, the report said. IMS expects five products each potentially worth at least $1 billion in annual sales to be approved and launched by the end of next year.
These medicines could include AstraZeneca Plc’s heart drug Brilinta, Bristol-Myers’ apixaban for blood clots, Sanofi- Aventis SA’s iniparib for breast cancer, the hepatitis C treatment telaprevir from Vertex Pharmaceuticals Inc. and Bristol-Myers’ ipilimumab for melanoma, Aitken said.
To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net
To contact the editor responsible for this story: Reg Gale in New York at rgale5@bloomberg.net.
Having full ownership of danoprevir increases our ability to rapidly develop combinations of our own hepatitis C compounds with molecules from other companies to maximize patient benefit."
I see the following in the 10K regarding roche terminating the agreement
On October 16, 2006, we entered into the Collaboration Agreement with Roche. Under the Collaboration Agreement, we agreed to collaborate with Roche to develop and commercialize products from our HCV protease inhibitor program. The Collaboration Agreement includes our lead candidate compound RG7227, which completed Phase Ib clinical trials. We also agreed to collaborate with Roche on a research program to identify, develop and commercialize novel second-generation HCV protease inhibitors. Assuming that we continue to successfully develop and commercialize these product candidates, under the terms of the Collaboration Agreement we are entitled to receive reimbursement and sharing of expenses incurred in connection with the development of these product candidates and additional milestone payments from Roche. As a result, Roche is providing 67% of the development costs for RG7227. In addition, if any of the product candidates we have licensed to Roche are approved for commercialization, we anticipate receiving proceeds in connection with the sales of such products. Roche may terminate the Collaboration Agreement in its entirety, in any country, subject to certain limitations for major countries, or with respect to any product or product candidate licensed under the Collaboration Agreement for any reason on six months’ written notice. If the Collaboration Agreement is terminated in whole or in part and we are unable to enter into similar arrangements with other collaborators, our business could be materially adversely affected.
ITMN could have opted out and saved development expenses according to whats in the 10k.
Due to cash constraints or for strategic business reasons we may decide to take certain actions that reduce our expenses. For example, based on our current anticipated timelines, during certain periods, one of which is in 2010, we will have the right under our collaboration agreement with Roche to opt out of the participation in the future development expenses of RG7227. If we elected to exercise this opt-out right, we would no longer be obligated to pay 33% of the development expenses related to RG7227 and Roche would thereafter be responsible for paying 100% of such development expenses; in lieu of receiving 50% of any profits in the United States to which we would otherwise have been entitled, we would receive royalty payments in the form of a percentage of net sales of RG7227 in the United States in the range of the high-teens to low-twenties percent; and we would receive larger milestones in connection with the filing and approval of our NDA in the United States. In addition, we would receive higher royalties on net sales of RG7227 in the rest of the world, and we would retain our current rights to receive all other milestones and our exclusivity rights would remain unchanged. Thus, if we decide to exercise our opt-out rights due to cash constraints, we would incur less expense but our rights to share profits from sales in the United States would be terminated and as a result our business and future financial results could be adversely effected.
Looks like they wanted the extra cash rather than hold on to 191. It also looks like Roche could have easily walked away from the agreement themselves so it looks like they may see some value in 191. Probably a deal beneficial to both parties. ITMN has a non dilutive way of getting money until an EMEA decision and Roche can do what it wants with 191.
Affymax® Announces Decision in Arbitration Against JNJ
Press Release Source: Affymax, Inc. On Wednesday October 6, 2010, 4:30 pm PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY - News) today announced that it has received a decision from the arbitration panel reviewing its dispute against certain subsidiaries of Johnson and Johnson (JNJ). The panel has determined that Affymax and JNJ are co-owners of certain intellectual property, including U.S. patent numbers 5,773,569, 5,830,851, 5,986,047, among others related to erythropoietin receptor agonists. In addition, the ruling determined that JNJ is sole owner of JNJ’s U.S. patent number 5,767,078 (‘078) and certain other related patents and patent applications in Europe, Japan, Canada and Australia.
“We are evaluating this decision to determine potential next steps in this litigation,” said Arlene M. Morris, chief executive officer of Affymax. “We continue to believe that these patents and patent applications do not encompass Hematide and that we can manufacture and sell the product upon approval.”
Affymax does not believe the claims in the ‘078 patent are valid. Even in the event that claims of this patent were found to be valid, Affymax believes that they do not encompass Hematide. The ‘078 patent purports to cover methods of dimerizing and activating the EPO receptor using covalently linked peptide monomers which do not activate the EPO receptor unless dimerized. Affymax asserts that Hematide does not infringe any of the claimed methods described in the ‘078 patent.
IMGN/Roche - New cancer data may be tonic for sickly Roche
Tue Oct 5, 2010 11:41am EDT * Roche drugs in focus at Oct 8-12 European cancer congress
* Ovarian cancer study could lift Avastin sales forecasts
* Roche filing for ovarian use in EU by end 2010, U.S. 2011
* Results due also with T-DM1 "armed antibody" at congress
By Ben Hirschler
LONDON, Oct 5 (Reuters) - Swiss drugmaker Roche (ROG.VX), battered by recent setbacks for key medicines, is banking on a batch of upcoming clinical trial data to restore belief in its pipeline.
News on Avastin in ovarian cancer and new drug T-DM1 in breast cancer will be closely watched by both investors and cancer doctors at the annual meeting of the European Society for Medical Oncology (ESMO) in Milan from Oct. 8 to 12.
Roche also hopes to impress experts with mid-stage clinical trial results of PLX4032, a new kind of pill against skin cancer, at a melanoma conference in Sydney next month.
"In the next few days and until the year-end we will see numerous highly exciting data on new molecular entities and line extensions," Stefan Frings, the company's leader for Avastin, told a Jefferies pharmaceuticals conference on Tuesday.
Roche certainly needs a pick-me-up. Its stock price is down 20 percent this year, making it the worst performer in the global large-cap drugs sector, following doubts about Avastin's future in breast cancer and other product setbacks.
The company announced in July that Avastin helped women with ovarian cancer live longer without their disease getting worse in a Phase III study, but analysts are anxious to see the details in order to model accurately the commercial opportunity.
Good clinical trials data could add $500 million to $1 billion to sales forecasts for Avastin, a product which sold $6 billion worldwide in 2009 as a treatment for bowel, breast, lung and other cancers, analysts believe.
Frings said Roche would file for European regulatory approval of Avastin in ovarian cancer by the end of the year, with a U.S. submission following in 2011.
"It's important, after all the setbacks Roche has had, that we are going to see more and more mid-stage clinical data to rebuild confidence in this part of its pipeline," said Vontobel analyst Andrew Weiss.
"It is important to remember this is not an imploding company. It is a research company."
ARMED ANTIBODY
The data on T-DM1 could help turn sentiment on an experimental drug whose image was tarnished in August when U.S. regulators rejected Roche's bid to gain marketing approval based only on mid-stage Phase II trials.
T-DM1 is viewed inside Roche as a key product. It is not only a potential improvement on the established blockbuster Herceptin but also the first of a new kind of "armed antibody" that can carry a cell-killing payload into cancer cells.
"It really does work. We have very strong Phase II data," Frings said.
The recent U.S. Food and Drug Administration decision was a disappointment and delayed T-DM1's path to market by two years. But, if anything, the setback increased its value, he added.
"We now have the opportunity, if those (Phase III) data pan out, to file in an earlier setting -- so not last-line but second-line -- and thanks to (President Barack) Obama healthcare any biologic now earns 12-year exclusivity, so the NPV (net present value) for us has gone up," Frings said.
After Milan, Roche will present keenly awaited Phase II data on its new melanoma drug at the International Congress of the Society for Melanoma Research in Sydney from Nov. 4 to 7. The drug has produced startling strong results in early tests, although its effect may be temporary. [ID:nN25151010] (Additional reporting by Katie Reid in Zurich; Editing by Sharon Lindores)
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