Premarket Biotech Digest – $TEVA loses patent, $LLY reports quarterly results, $RIGL announces trial results
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Mylan NV ($MYL) announced that it is being investigating by the US antitrust authorities for its EpiPen emergency allergy treatment. The company was earlier asked for information by the Federal Trade Commission as part of a preliminary investigation. The company had been severely criticized for raising the price of a pair of EpiPens to $600 from $100 in 2008. The company was also berated for listing EpiPen with Medicaid as a generic product despite it being listed with the U.S. Food and Drug Administration as a branded product.
However, Mylan also received a little reprieve as a United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to Copaxone® 40 mg/mL invalid based on obviousness. The patents belonged to Teva. Mylan is looking to bring the generic version of this MS drug.

Teva Pharmaceuticals ($TEVA) saw a massive tumble in its stock price as a US court rejected the company’s 4 Copaxone patents. The drug is the best seller for the company and is prescribed for multiple sclerosis. In 2016, the US patent officials had rendered three patents on the same drug invalidated. he U.S. District Court of Delaware said in a ruling on Monday that all asserted claims of Teva were invalid.
These patents are scheduled to expire in2030 and cover a 40-milligram injection of Copaxone that needs to be administered three times a week. The company now plans to appeal the decision. The ruling is important as it may pave the way for other companies to sell their generic versions.
However, the company has simultaneously won U.S. approval to market a copy of GlaxoSmithKline's best-selling Advair inhaler.

 

• Rigel Pharmaceuticals ($RIGL) reported sustained treatment benefit in patients with chronic immune thrombocytopenic purpura (ITP) receiving fostamatinib in a long-term Phase 3 extension study (Study 049). The company intends to file a marketing application in the U.S. this quarter.
• Gamphire Therapeutics ($GEMP) reported that its gemcabene demonstrated a significant treatment effect after eight weeks of treatment in a Phase 2b study in patients with genetic high cholesterol called homozygous familial hypercholesterolemia (HoFH). Orphan Drug-tagged gemcabene is a once-daily orally available medication for patients unable to achieve normal levels of LDL-C or triglycerides with currently available therapies.

• Allergan ($AGN) announced receiving the FDA approval for revising the label of AVYCAZ (ceftazidime and avibactam) to include data from two Phase 3 studies in patients with complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection), caused by designated susceptible Gram-negative bacteria. AVYCAZ was approved in the U.S. for the treatment of adult patients with complicated intra-abdominal infections in February 2015. It was approved for cUTI, including pyelonephritis, in June 2016.
• Ocera Therapeutics ($OCRX) reported that a Phase 2b clinical trial, STOP-HE, assessing lead product candidate OCR-002 (ornithine phenylacetate) in hospitalized patients with hepatic encephalopathy (HE) failed to beat placebo. It also failed to differentiate itself from placebo in the secondary endpoint of median time to complete response in HE symptoms. However, the under-trial patients showed a statistically valid reduction in the time to achieve normal plasma ammonia levels versus placebo (p=0.028), an exploratory endpoint.

 
• ESSA Pharma ($EPIX) announced receiving $4 million from the Cancer Prevention Research Institute of Texas under a $12M grant. The grant was originally awarded in February 2014. The grant will be used for covering certain expenses incurred by ESSA in its ongoing Phase 1 dose escalation study of prostate cancer candidate EPI-506 and costs associated with the preparation for a Phase 2 dose expansion study.

 
• Corcept Therapeutics Inc. ($CORT) announced its 2016 revenue at $81.3 million, up 62 percent. Its fourth quarter revenue stood at $23.8 million, a 59 percent increase from fourth quarter 2015. For the full year, the company reported preliminary GAAP net income of $0.07 per share, compared to a net loss of $0.06 per share in 2015. Preliminary GAAP net income for the fourth quarter was $0.04 per share, compared to net income of $0.01 per share in the fourth quarter of 2015. The company’s revenue guidance for 2017 is in the range of $115 - 125 million.
• Eli Lilly ($LLY) reported its that net income rose to $771.8 million, or $0.73 per share, in the fourth quarter, up from $478.4 million, or $0.45 per share, a year earlier. Its revenue stood at $5.76 billion, up from $5.38 billion. The company said that its revenue for the quarter rose 7.2 percent on account of higher demand for its diabetes drug Trulicity and other new treatments.

• Biogen Inc. ($BIIB) received Buy rating from H.C. Wainwright. The price target for the stock has been set at $360.
• Dexcom ($DXCM) received Buy rating from Oppenheimer. The price target for the stock has been set at $98.

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