Vivus up 4% on advancement of Qsymia in Europe

Thinly traded nano cap VIVUS (VVUS +4.3%) is up, albeit on very light volume, on the heels of its announcement that that its marketing application in Europe seeking approval of Qsymia (phentermine and topiramate extended-release) has been accepted for review by lead member state Sweden. If approved, the weight loss med will be authorized for sale throughout the EU as early as H2 2020 under its decentralized procedure.

The FDA approved it in July 2012.

https://seekingalpha.com/news/3504235-vivus-4-percent-advancement-qsymia-europe

UCB challenges Roche patent covering IL-17-targeting antibodies

Based on a petition from UCB S.A. (OTCPK:UCBJF), the USPTO’s Patent Trial and Appeal Board (PTAB) will review the validity of Roche (OTCQX:RHHBY +0.4%) unit Genentech’s U.S. Patent No. 10,011,654 covering antibodies that target interleukin-17A, a proinflammatory cytokine.

The patent is part of a lawsuit that Genentech filed against Eli Lilly (LLY +0.2%) last year claiming its entitlement to royalties on arthritis med Taltz (ixekizumab), an IL-17A inhibitor. Lilly disagrees and has also filed a petition with the PTAB.

https://seekingalpha.com/news/3504267-ucb-challenges-roche-patent-covering-ilminus-17-targeting-antibodies

Bristol-Myers sues Dr. Reddy’s to block generic Sprycel

Bristol-Myers Squibb (BMY +0.7%) has filed a lawsuit in a New Jersey court against Dr. Reddy’s Laboratories (RDY -0.6%) in an attempt to block the commercial entry of the latter’s generic version of leukemia med Sprycel (dasatinib). It claims that RDY’s product infringes on two patents that expire in 2025 and 2026, respectively.

Sprycel accounted for 8.5% ($1,003M) of BMY’s H1 product sales of $11,744M.

https://seekingalpha.com/news/3504307-bristol-myers-sues-dr-reddys-block-generic-sprycel

Illumina and Qiagen in long-term IVD diagnostics partnership

Illumina (NASDAQ:ILMN) and QIAGEN N.V. (NYSE:QGEN) have entered into a 15-year agreement aimed at developing and commercializing next-gen sequencing-based in vitro diagnostic (IVD) test kits.

Under the terms of the partnership, QGEN will have non-exclusive rights to develop and commercialize IVD kits that can be used with ILMN’s MiSeq Dx and NextSeq 550Dx Systems, including the rights to expand the deal into future ILMN diagnostic systems.

The parties will also commercialize a lineup of clinically validated workflows that combine QGEN’s proprietary content and bioinformatics solutions.

Financial terms are not disclosed.

https://seekingalpha.com/news/3504316-illumina-qiagen-ink-long-term-ivd-diagnostics-partnership

Qiagen prelim Q3 top line less than expected

On a preliminary basis, Q3 sales growth for QIAGEN N.V. (NYSE:QGEN) will be ~3% on a constant exchange rate basis versus guidance of 4 – 5%, due mainly from softer sales in China.

Non-GAAP EPS should be within its guided range of $0.35 – 0.36.

Complete results will be released on October 30.

On another note, Chairman and CEO Peer Schatz has decided to step down in the coming weeks, continuing as a Special Advisor to assist in the transition to new leadership. A search for a permanent CEO has been initiated. In the interim, CFO Roland Sackers will take the reins.

Shares up 1% after hours.

https://seekingalpha.com/news/3504319-qiagen-q3-top-line-less-expected

Intersect ENT down on failed study of drug-coated sinus balloon

Intersect ENT (NASDAQ:XENT) slumps 26% premarket on light volume in reaction to unsuccessful results from the randomized ASCEND study evaluating its drug-coated sinus balloon for dilating the frontal sinus ostium to reduce post-balloon dilation edema via the localized delivery of steroid directly to dilated tissue.

The drug-coated sinus balloon failed to beat an uncoated balloon control as measured by sinus patency grade at day 30, the primary endpoint. Several secondary endpoints were met, including reductions in inflammation and polypoid edema.

No safety signals were observed.

The company will further analyze the results before deciding on next steps.

https://seekingalpha.com/news/3504148-intersect-ent-26-percent-premarket-failed-study-drug-coated-sinus-balloon

Akcea out-licenses antisense candidate to Pfizer for up to $1.5B

Ionis Pharmaceuticals (NASDAQ:IONS) affiliate Akcea Therapeutics (NASDAQ:AKCA) inks an agreement with Pfizer (NYSE:PFE) for global rights to antisense drug AKCEA-ANGPTL3-Lrx for certain cardiovascular and metabolic diseases.

Under the terms of the deal, Akcea and Ionis will receive $250M upfront, divided equally, up to $1.3B in milestones and tiered double-digit royalties on net sales. Akcea will settle its $125M obligation to Ionis via common stock instead of cash.

Pfizer will be responsible for all development and regulatory activities beyond the ongoing Phase 2 trial.

Akcea has the right to participate in certain commercialization activities in the U.S. and selected other markets based on predefined terms and criteria.

AKCEA-ANGPTL3-Lrx is designed to reduce the production of a protein called angiopoietin-like 3, a key regulator of a range of lipid and metabolic pathways. The absence of the protein is associated with reduced risk of insulin resistance and diabetes.

https://seekingalpha.com/news/3504157-akcea-licenses-antisense-candidate-pfizer-1_5b