Last week, there was a slight recovery in the biotech sector with NASDAQ Biotechnology improving 2.19% and the NYSE ARCA Biotech Index gaining 3.27%. Most of the major biotech companies saw an improvement in their share prices. Meanwhile, several companies reported earnings and provided regulatory and pipeline updates.
Endocyte (ECYT) Tumbles on Study Halt: Endocyte plunged 61.9% on news that a phase III study (:PROCEED) being conducted with its experimental cancer treatment, vintafolide, will be halted on the recommendation of a data safety monitoring board (:DSMB).
An interim futility analysis of the ovarian cancer study showed that vintafolide did not demonstrate efficacy on the pre-specified outcome of progression-free survival. The positive takeaway is that no safety issues were identified. A lung cancer study will continue.
Acorda Down on CRL: Acorda’s shares were down 9.8% on a complete response letter (CRL) from the FDA for Plumiaz nasal spray. Acorda was looking to get Plumiaz approved for treatment of people with epilepsy who experience cluster seizures. However, the FDA said that the regulatory application cannot be approved in the present form.
Acorda had used the 505(b)(2) pathway using Diastat as the reference drug to seek approval. Given the current situation, Acorda said that it does not expect FDA approval this year. Additional clinical work will most likely be required though at present there’s low visibility on how much time and cost this will involve. If the delay is significant, Pfizer’s experimental product which also has orphan drug status could reach the market first.
Pharmacyclics (PCYC) Slips on Guidance: Despite delivering first quarter results far above expectations, Pharmacyclics saw its shares slipping 7.4% on disappointing guidance. Imbruvica, which has blockbuster potential, delivered sales of $56.2 million in its first full quarter on the market.
The main concern regarding Pharmacyclics’ results was guidance -- the company guided towards product sales of $295 million, plus or minus 5%. Though this guidance does not include milestone payments, nevertheless it was short of expectations. With Imbruvica approved for the more lucrative chronic lymphocytic leukemia indication as well, expectations were high that Imbruvica sales would soar significantly through the rest of the year and this would be reflected in the guidance.
OncoGenex Slumps on Late-Stage Data: OncoGenex saw its shares losing more than half their value (down 60.3%) on news that the company’s experimental prostate cancer drug, custirsen, failed to meet the primary endpoint in a late-stage study.
Merrimack (MACK) Soars on Pancreatic Cancer Data: Merrimack reported positive results from a phase III study on its pancreatic cancer experimental treatment -- MM-398. MM-398, when used in combination with chemotherapy increased overall survival by 1.9 months compared to chemotherapy alone. This is encouraging data considering pancreatic cancer is extremely difficult to treat and there have been very few successful phase III trials in pancreatic cancer in the past 25 years. The mortality rate for pancreatic cancer, which is the fourth most common cause of cancer death, is very high.
The study was conducted in patients who had been previously been treated with Gemzar. Although MM-398 did not achieve much success as a monotherapy, investors focused on the combination treatment data and sent the shares soaring 59.2%. The company will file for FDA approval this year.
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Vertex (VRTX) Drops Hepatitis C Portfolio: Vertex, which was once known for changing the treatment paradigm for hepatitis C virus (:HCV) following the launch of Incivek, has decided to exit this market. The company will now focus on its cystic fibrosis portfolio.
The decision doesn’t really come as a surprise. Incivek’s sales slumped almost 60% last year due to the warehousing effect -- patients and physicians postponing treatment with existing drugs so as to avail better new treatments once they are launched. With Gilead’s Sovaldi on the market, Incivek sales would have slumped further this year. So, it makes sense for the company to focus on its cystic fibrosis franchise which is doing well.
CRL for The Medicines Co.’s Cangrelor: The FDA issued a CRL to The Medicines Co. for its investigational antiplatelet agent, Cangrelor. This was in line with expectations as earlier an FDA advisory panel had voted against approving the drug.
Auxilium Cuts Guidance: Less than a week before reporting first quarter results, Auxilium announced a guidance cut mainly due to lower-than-expected Testim revenues. The company cut its revenue guidance for 2014 by $70 million and now expects to break-even or report a loss of up to $15 million this year instead of reporting net income of $45 million - $50 million.
Full year Testim sales are expected to be less than $85 million due to several factors like a shrinking testosterone replacement therapy (TRT) gel market, lower Testim market share, downward pressure on TRT gel scrips due to concerns regarding safety, inventory destocking, and higher rebates. Although Auxilium has been working on diversifying its revenue base, Testim sales came in at $211.2 million in 2013, accounting for 52.7% of the company’s revenues in 2013.
EU Approves BioMarin’s Vimizim: Vimizim gained EU approval for Morquio A syndrome that is estimated to affect 3,000 people in the developed world.
Approval was largely expected as the CHMP had issued a positive opinion in February. EU approval, nevertheless, is a major boost for the company -- with the U.S. accounting for only 15% of the 1,500 patients identified by BioMarin, EU approval was a key milestone for the company. Vimizim will enjoy 10 years market exclusivity in the EU due to its orphan drug status.
Amicus Up on Fabry Disease Data: Amicus’ experimental Fabry disease drug was found to be effective in a late-stage study. Shares were up 20.7% on the news.
Athersys Plunges on Disappointing Data: Athersys’ shares plunged 51.3% on disappointing interim data from mid-stage study on the administration of its MultiStem cell therapy for the treatment of refractory ulcerative colitis.
The Week So Far:
Priority Review for Medivation’s (MDVN) Xtandi: Medivation and Astellas’ prostate cancer drug, Xtandi, has been accepted for priority review by the FDA for the treatment of chemo-naïve patients. This means a response will be out by Sep 18.
Momenta Facing Possible Delay in Generic Copaxone Launch: Momenta Pharmaceuticals’ shares were down 7.6% shortly after the company reported first quarter results. Shares were down on concerns regarding the timing of the company’s launch of its generic version of Teva’s Copaxone.
Theravance on Track to Split: Theravance will be splitting into two companies -- Theravance, Inc. (the royalty management company) and Theravance Biopharma, Inc. (the R&D company) – around Jun 2.
Vivus Up on First Quarter Results: Vivus’ shares were up 7.2% on the company’s better-than-expected first quarter results. However, a closer look at results show that the revenue beat was mainly driven by license and milestone payments.
Regeneron (REGN) Ties Up with Avalanche: Regeneron, which has blockbuster eye drug Eylea in its portfolio, is looking to bring additional eye disease treatments to market. The company is tying up with privately held Avalanche Biotechnologies, which specializes in developing gene therapies for eye diseases.
Regular Approval for Alexion’s (ALXN) Soliris: Alexion has gained regular FDA approval for Soliris for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS).
Several companies including Regeneron will be reporting earnings later this week.
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