Sumitomo Dainippon Pharma Positive Topline Results in Phase 3 Antipsychotic

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura hereinafter called ‘Sumitomo Dainippon Pharma’) announced today that topline results from a Phase III clinical study (JEWEL study, ‘this study’) evaluating lurasidone hydrochloride (generic name, ‘lurasidone’), an atypical antipsychotic in the treatment of patients with schizophrenia met its primary endpoint and demonstrated a favorable tolerability profile of lurasidone.

The Phase III study was conducted to support regulatory approval in Japan.

This study was a multi-center, placebo-controlled, randomized, double-blind, 6-week study intended to evaluate the efficacy and safety of lurasidone 40 mg/day vs. placebo, involving 483 patients with schizophrenia.

Using the pre-specified primary analysis in the ITT (Intent to Treat) population (n=478), the lurasidone group (245 patients) demonstrated statistically significant improvement compared to the placebo group (233 patients) in the primary endpoint of change from baseline of the PANSS (Positive and Negative Syndrome Scale) 1 total score after 6 weeks of study treatment [-19.3 in the lurasidone group and -12.7 in the placebo group (p

https://www.marketscreener.com/SUMITOMO-DAINIPPON-PHARMA-6492512/news/Sumitomo-Dainippon-Pharma-Announces-Positive-Topline-Results-from-a-Phase-III-Clinical-Study-of-Lu-27854091/

Actavis Infringes Orexo’s Long Term Zubsolv® U.S. Patent ´330

Orexo AB (publ.), the fully integrated specialty pharmaceutical company addressing opioid addiction and pain, today announces that the United States District Court for the District of Delaware has issued a final, non-appealable judgement that Actavis‘s generic Zubsolv products infringe Orexo’s U.S. patent No. 8,940,330. The judgement will prevent Actavis from commercializing their infringing generic Zubsolv products in the U.S. until after September 18, 2032.

The infringement judgement now issued by the District Court follows from the decision from the U.S. Court of Appeals for the Federal Circuit on September 10, 2018, that the ‘330 patent is valid. The infringement judgement involves all dosage strengths of Actavis’s generic Zubsolv products. As a result of the favourable infringement judgement, Orexo’s lawsuits against Actavis involving U.S. Patent Nos. 9,259,421 and 9,439,900, also protecting Zubsolv in the US until September 18, 2032, have been withdrawn.

This infringement judgement does not relate to the litigation against Actavis where Orexo alleges that Actavis’s generic versions of Suboxone and Subutex tablets infringe Orexo’s U.S. Patent No. 8,454,996.

“Although expected, I am very pleased that we now have a final judgement preventing Actavis from commercializing its generic Zubsolv products in the US until September 2032. It has been an extraordinarily long process and I want to thank my team, the Board of Directors and the shareholders who never doubted we would succeed. We are now looking forward to focus on expanding our commercial platform to leverage scale and increase revenues,” said Nikolaj Sørensen, President and CEO, Orexo AB.

https://www.biospace.com/article/releases/actavis-infringes-orexo-s-long-term-zubsolv-u-s-patent-330/

Generex subsidiary Olaregen plans launch of Excellagen with 3 dose options

Generex Biotechnology Corporation announced that Olaregen Therapeutix, a subsidiary of Generex Biotechnology will launch three doses of FDA 510K-Cleared Excellagen, the company’s wound conforming gel matrix that is designated as a Cellular & Tissue Based Product or CTP for wound healing. The 0.5 cc and a 0.8 cc syringes will be utilized to treat smaller wounds such as diabetic foot ulcers, venous stasis ulcers, and pressure ulcers, and in patients who have undergone MOHs surgery for removal of cancerous tissue. The 3 cc syringe has been developed for larger wounds that are most frequently seen in emergency departments, operating rooms, and surgical suites. Excellagen has a designated reimbursement code in the Healthcare Common Procedure Coding System, with a unique Q Code designation 4149 referred to as a skin substitute. The Excellagen launch team is introducing the product in surgical centers, the Department of Defense and VA system, operating rooms, and wound care centers, as well as through podiatric practices. The company is currently in contract negotiations with major nation-wide surgical wound care centers for the use of Excellagen for the treatment of a variety of wound types, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds and draining wounds. Additionally, NuGenerex Distribution Solutions, a wholly-owned subsidiary of Generex, will immediately launch Excellagen through its MSO network of surgeons and podiatrists in five states. https://thefly.com/landingPageNews.php?id=2847554

Aratana Therapeutics downgraded to Hold from Buy at Stifel

Stifel analyst Jonathan Block downgraded Aratana Therapeutics to Hold and lowered his price target for the shares to $5 from $8. While the company is seeing ongoing Entyce adoption, little progress has been made on lengthening the drug’s duration, Block tells investors in a research note. He lowered his 2019-2024 Entyce estimates “materially,” and when coupled with a “modest” pipeline, recent COO departure and a key shareholder reducing its position, the analyst is moving to the sidelines.

https://thefly.com/landingPageNews.php?id=2847303

Humana upgraded to Outperform on pullback, improving outlook at Cowen

Cowen analyst Charles Rhyee upgraded Humana to Outperform from Market Perform, noting that the company revised up its net membership growth estimate for its individual MA products for 2019 at the end of November and then bumped it up again more recently. Rhyee raised his 2019 estimates for Humana, adding that he sees room for additional upside given the company’s room to lever up to fund M&A or share buybacks. Additionally, the pullback in shares this past fall seems to have removed a premium for a potential takeout, which he does not think was warranted given the lack of likely buyers, Rhyee said. He maintains a $372 price target on Humana shares.
https://thefly.com/landingPageNews.php?id=2847361

Halozyme undervalued relative to ‘de -risked’ assets, says Wells Fargo

Wells Fargo analyst Jim Birchenough reiterates an Overweight rating on Halozyme Therapeutics following this week’s update and 2019 outlook. The analyst continues to view the company as undervalued relative to its “highly de -risked” lead Enhanze assets. He sees “significant option value” to the broader Enhanze opportunity and PEGPH20 data.
https://thefly.com/landingPageNews.php?id=2847405

Cantel acquires Vista Research Group

Cantel Medical (NYSE:CMD) has acquired Vista Research Group, LLC for total purchase price of ~$10.5M in cash, consisting of $7M in an upfront payment and $3.5M in an earnout payment on achieving certain targets.

https://seekingalpha.com/news/3422358-cantel-acquires-vista-research-group