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Tuesday, January 7, 2020

Amgen prevails in appeal of adverse patent ruling on Sensipar

The U.S. Court of Appeals for the Federal Circuit has vacated a lower court ruling clearing Amneal Pharmaceuticals (AMRX -3.6%) of infringing on an Amgen (AMGN -0.8%) patent covering Sensipar (cinacalcet) and has sent the case back to the Delaware district court for further action.
The appeals court found that Zydus Pharmaceuticals’ generic offering infringes while Piramal Pharma Solutions’ does not.

Advaxis up on advancement of prostate cancer candidate into clinic

Nano cap Advaxis (ADXS +22.4%) jumps on a more than double normal volume in reaction to the FDA’s sign-off on its IND for a Phase 1 study evaluating ADXS-504 in prostate cancer patients.
ADXS-504 is the company’s ADXS-HOT candidate for the indication, an off-the-shelf neoantigen that targets hotspot mutations in tumor driver genes.

Protagonist Therapeutics earns $5M milestone from Janssen; shares up

Protagonist Therapeutics (PTGX +4%) has earned a $5M milestone payment from licensee Janssen Biotech, a unit of Johnson & Johnson, triggered by the latter’s nomination of a second-generation development candidate.
The companies are jointly conducting a 90-subject Phase 2 proof-of-concept study evaluating the first-generation candidate, oral  IL-23 receptor antagonist PTG-200 (JNJ-67864238), in Crohn’s disease patients.
The parties inked their original agreement in August 2017 and expanded it in May 2019 to include second-generation IL-23 receptor antagonists.

Ensign acquires The Healthcare Center at Patriot Heights

Ensign (ENSG -1%) has acquired the real estate and operations of The Healthcare Center at Patriot Heights, a healthcare campus with 59 skilled nursing beds and 158 independent living units located in San Antonio, Texas.
This acquisition brings Ensign’s portfolio to 214 skilled nursing operations. Ensign owns the real estate at 90 healthcare operations.

MedRisk acquires Select Provider Networks

MedRisk has acquired Select Provider Networks from Select Medical (SEM -2%).
SPNet provides a boutique specialty network of physical and occupational therapists to the workers’ compensation industry.
Under the new MedRisk ownership, SPNet will retain its name and operate independently.
“SPNet and MedRisk may have very different managed care programs, but one thing we share is a commitment to quality care for injured workers,” said MedRisk CEO Mike Ryan.
The purchase price was not disclosed.

AbbVie loses bid to reverse adverse ruling on Humira patents

Without issuing an opinion, the U.S. Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision invaliding three patents (Nos. 8,889,135, 9,017,680 and 9,073,987) covering AbbVie’s (ABBV -0.5%) top seller Humira (adalimumab).
The patents were challenged by Coherus BioSciences (CHRS -1%) and privately held Boehringer Ingelheim, both of which have already settled with AbbVie.

Monday, January 6, 2020

Merck’s Keytruda shows mixed results in late-stage lung cancer study

A Phase 3 clinical trial, KEYNOTE-604, evaluating the combination of Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and chemo (etoposide plus cisplatin or carboplatin) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) showed a statistically significant improvement in progression-free survival (PFS) compared to chemo alone, one of the primary endpoints.
The other primary endpoint, overall survival (OS), favored the Keytruda combo but the separation from chemo was not statistically valid.
No new safety signals were observed.
The data will be presented at an upcoming medical conference and reviewed with regulatory authorities.