LLY Gets FDA Nod, MRK Scores Legal Win, AFFX Pursued By Origin Technologies

(RTTNews) - Anacor Pharmaceuticals Inc.'s (ANAC) New Drug Application seeking approval of Crisaborole topical ointment, 2%, for the potential treatment of mild-to-moderate atopic dermatitis in children and adults has been accepted for review by the FDA. The regulatory agency's decision is scheduled for January 7, 2017.

ANAC closed Tuesday's trading at $59.99, up 0.77%.

Aratana Therapeutics Inc. (PETX) has sought approval for ENTYCE, a first-of-its-kind therapeutic, to treat inappetence in dogs. A decision is expected on May 21, 2016. If approved, this will be the company's second drug to receive the regulatory nod.

On March 21, 2016, the company received its first approval for GALLIPRANT for the control of pain and inflammation associated with osteoarthritis in dogs. Galliprant is expected to be available to veterinarians in fall 2016.

PETX closed Tuesday's trading at $4.86, down 6.36%.

Eli Lilly and Co.'s (LLY) Taltz has received FDA approval for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

The active substance of Taltz is ixekizumab, and is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended Taltz for the treatment of plaque psoriasis. A final decision by the European Commission is announced within two to three months of the CHMP issuing its recommendation.

This injectable drug is also being explored in the treatment of patients with active psoriatic arthritis. Analysts expect Taltz to be a blockbuster if it is approved for the two indications.

LLY closed Tuesday's trading at $71.92, up 2.38%.

Insys Therapeutics Inc. (INSY) will now have to wait until July 1, 2016 to know the FDA's decision on Syndros, its drug candidate developed for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy.

The regulatory agency's decision was originally scheduled for April 1, 2016.

Insys voluntarily submitted information, which did not involve any clinical data, related to the scheduling of Syndros under the Controlled Substances Act. It was considered a major amendment to the NDA, resulting in the FDA requiring additional time to complete its review.

INSY closed Tuesday's trading at $20.46, up 8.83%.

The U.S. District Court has ruled in favor of Merck & Co. Inc. (MRK) and Ionis Pharmaceuticals Inc. (IONS) in a patent dispute related to Gilead's (GILD) Sofosbuvir-based medicines for the treatment of hepatitis C virus, including Sovladi and Harvoni.

In 2013, Merck had sought royalties from Gilead on the sales of Sofosbuvir claiming that it infringed on its patents. Following Merck's claims, Gilead filed a suit in the U.S. District Court for the Northern District of California seeking declaratory judgment that the Merck patents are invalid and not infringed.

Ionis and Merck are co-inventors on the patents that serve as the basis for the dispute.

Now that the case has gone against Gilead, it will have to pay damages to Merck as compensation for its past and future infringement. Ionis will receive 20% of the damages awarded to Merck that exceed the costs Merck incurred to conduct the litigation and Ionis will also receive 20% of all future payments.

Gilead's Harvoni brought in sales of $13.86 billion while Sovaldi generated sales of $5.28 billion for the full year of 2015.

MRK closed Tuesday's trading at $53.03, up 0.44%.

MYOS Corp. (MYOS) has changed its corporate name to MYOS RENS Technology Inc., and its common stock will continue to be listed on the Nasdaq Capital Market under the symbol "MYOS."

The name change reflects the important alignment between MYOS, dealing in bionutrition and biotherapeutic products, and affiliates of RENS Technology Inc., including RENS Agriculture Science & Technology Inc., focused on food freezing technology in China and an innovator in the science of preserving the integrity of food-derived proteins.

MYOS closed Tuesday's trading at $1.85, up 10.12%.

Origin Technologies Corp. LLC, which is pursuing a rival bid for Affymetrix Inc. (AFFX), has raised its offer to $17.00 per share from its earlier offer of $16.10 per share in cash.

Origin has also agreed to increase the size of its reverse termination fee to $100 million and also intends to include a "hell or high water" provision in the merger agreement obligating itself to take any and all actions required to obtain regulatory approvals, in the event they are required.

Affymetrix already has an agreement in place, signed in January of this year, to be acquired by Thermo Fisher Scientific Inc. for $14 a share in cash, or a purchase price of approximately $1.3 billion. The agreement was unanimously approved by both boards of directors, and the transaction is expected to be completed by the end of June.

Will Affymetrix accept the revised offer from Origin or will it remain committed to be acquired by Thermo Fisher? Time will tell.

AFFX closed Tuesday's trading at $14.37, down 0.21%.

Osiris Therapeutics Inc. (OSIR) has been notified that it is not in compliance with NASDAQ Listing Rule for failing to file its Annual Report for the year ended December 31, 2015 on a timely basis with the Securities and Exchange Commission.

The company is required to submit a plan within 60 days to regain compliance with NASDAQ's filing requirements for continued listing.

OSIR closed Tuesday's trading at $5.71, up 3.82%.