Biotech Stock Roundup: Biogen Drug Approved, Exelixis Tumbles on Study Update - Analyst Blog

Weakness in the biotech sector continued last week. The selloff, which was triggered by concerns raised by lawmakers regarding the pricing of Gilead's GILD hepatitis C virus (HCV) drug, Sovaldi, continued with several major companies seeing a decline in their share price. Efforts to stage a comeback were in vain with NASDAQ Biotechnology declining 7.0% and the NYSE ARCA Biotech Index declining 6.7% at the end of the week.

Meanwhile, it was business as usual with highlights being pipeline setbacks, FDA approvals, and data presentation.

Exelixis EXEL Tumbles on Trial Update: Exelixis plunged 39.3% on news that the Independent Data Monitoring Committee (IDMC) for the company's phase III COMET-1 study on cabozantinib recommended that the study should continue. Apparently, expectations were high that the IDMC would halt the study early on strong efficacy signals as in the case of drugs developed by other companies for the same indication. But this did not happen for cabozantinib and investors expressed their disappointment.

Cabozantinib, which is already approved under the trade name Cometriq for thyroid cancer, is being evaluated in the COMET-1 study for prostate cancer. With the IDMC saying the study should continue, results will be available later this year.

Insmed Down on Mixed Data: Insmed shares were down 13.1% with the company reporting mixed data on its lead pipeline candidate, Arikayce (an inhaled antibiotic being developed for the treatment of patients suffering from treatment resistant nontuberculous mycobacterial lung infections). While Arikayce failed to meet the primary endpoint in a mid-stage study, the company said that the experimental drug achieved statistical significance for a clinically relevant key secondary endpoint - culture conversion. However, investors were not too reassured by these results and sent the stock down.

Idera Surges on Phase II Data: Idera saw its shares soaring 17.8% on encouraging mid-stage data from its toll-like receptor TLR program. The company said that lead pipeline candidate, IMO-8400, met the primary endpoint in a study conducted for moderate to severe plaque psoriasis. The results support the continued development of IMO-8400 and the company's other TLR candidates.

Active Week for PCSK9 Inhibitors: Last week saw Amgen AMGN coming up with more positive data on its PCSK9 inhibitor, evolocumab. But Pfizer is not far behind. Pfizer said that its PCSK9 inhibitor, bococizumab, met the primary endpoint (significant reduction in “bad” cholesterol) in a phase IIb study. These results bode well for an ongoing phase III program.

FDA Says Yes to Biogen BIIB Drug: Biogen gained FDA approval for its hemophilia B treatment, Alprolix, a few days after gaining approval in Canada. Alprolix will be available from early May. A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help Alprolix capture share from existing products in the hemophilia market. However, initial uptake will most likely be modest as the hemophilia market is historically slow-moving with patients and physicians being reluctant to switch treatments without real-world experience.

The Week So Far:

This week has turned out to be pretty eventful so far with a few FDA panel meetings, court rulings, and regulatory updates.

Third Time Lucky for MannKind's MNKD Afrezza? After a choppy start to the week when concerns regarding FDA briefing documents on Afrezza surfaced, MannKind investors had a lot to cheer about – an FDA advisory panel voted in favor of approving Afrezza for type I (13-1) and type II (14-0) diabetes. Shares were up significantly in pre-market trading.

Partial Hold on Curis Study Lifted: A partial clinical hold placed by the FDA on Curis' experimental cancer drug, CUDC-427, was lifted earlier this week.

Amarin-Kowa to Co-Promote Vascepa: Amarin is collaborating with Kowa Pharmaceuticals for the promotion of its flagship product, Vascepa, in the U.S.

Cubist CBST Drug Closer to FDA Approval: Cubist investors had a good start to the week with the company receiving a favorable recommendation from an FDA advisory panel for its experimental anti-infective drug – Sivextro (tedizolid). Shares were up 4.4%.

Regeneron REGN Armed with PCSK9 Data: Regeneron and partner Sanofi were not to be left behind where positive data on PCSK9 inhibitors is concerned. The companies said that their experimental PCSK9 inhibitor, alirocumab, lowered “bad” cholesterol significantly in Japanese patients.

The Medicines Co.'s MDCO Shares Tumble: The week so far has not been great for The Medicines Co. – shares fell 16.5% on an unfavorable trial opinion in a patent infringement lawsuit regarding Angiomax.

Celgene CELG Bets on Forma: Celgene expanded its relationship with Forma Therapeutics which is focused on oncology and other genetically driven therapeutic areas. The collaboration, which could see Celgene paying up to $600 million (including an upfront payment of $225 million), could ultimately result in Celgene acquiring Forma.

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