EXEL, PFE, ONCE Get FDA Nod, FPRX, ZLAB Team Up, SKLN Soars After Hours

(RTTNews) - Today's Daily Dose brings you news about FDA approvals of EXEL, Medicure, Pfizer and Spark; collaboration deals of Biogen & Ionis, and Five Prime & Zai Lab; Skyline's purchase of equity stake in a precision diagnostic company and TherapeuticsMD's second attempt to get approval for TX-004HR in the treatment of vulvar and vaginal atrophy in postmenopausal women.

Read on...

Biogen (BIIB) and Ionis Pharmaceuticals Inc. (IONS) are teaming up to identify new antisense oligonucleotide drug candidates for the treatment of spinal muscular atrophy.

Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization.

As per the terms of the deal, Ionis will receive a $25 million upfront payment and will earn development and regulatory milestone payments from Biogen if new drugs advance towards marketing approval. Upon commercialization, Biogen will pay Ionis performance milestones and tiered royalties on net sales.

IONS closed Tuesday's trading at $50.93, down 2.60%. In after-hours, the stock gained 1.90% to $51.90.

Exelixis Inc.'s (EXEL) supplemental New Drug Application for CABOMETYX as first-line monotherapy for advanced renal cell carcinoma has been approved by the FDA. The original decision date is February 15, 2018.

CABOMETYX was approved by the FDA for the treatment of patients with advanced renal cell cancer who have received prior anti-angiogenic therapy in April 2016.

During the third quarter of 2017, CABOMETYX generated $90.4 million in net product revenue.

EXEL closed Tuesday's trading at $26.68, up 2.34%.

Five Prime Therapeutics Inc. (FPRX) and Zai Lab Limited (ZLAB) have announced an exclusive license agreement for FPA144 in Greater China and global strategic development collaboration.

A phase 1/3 clinical trial to test the combination of Five Prime's FPA144 with front-line chemotherapy in patients with metastatic gastric and gastro-esophageal junction cancer is getting started.

Last month, Five Prime said that it plans to begin dosing patients in the Phase 1 portion of the FIGHT Phase 1/3 clinical trial by the end of 2017. The Phase 3 portion of the FIGHT trial is expected to start in the second half of 2018. Zai Lab will manage the Phase 3 portion of the trial in China.

While Zai Lab gains an exclusive license to develop and commercialize FPA144 in the Greater China territory: China, Hong Kong, Macau, and Taiwan, the deal entitles Five Prime to receive a $5 million upfront payment and up to $39 million in development and regulatory milestone payments. Five Prime is also eligible to receive from Zai Lab a royalty percentage on net sales of FPA144 in Greater China ranging from the high teens to the low twenties.

FPRX closed Tuesday's trading at $20.96, up 0.94%.

Fuse Medical Inc. (FZMD.OB), a provider of a broad portfolio of orthopedic implants, is all set to acquire CPM Medical Consultants, LLC, a privately-owned nationwide distributor of medical device implants and biologics.

CPM will become a wholly-owned subsidiary of Fuse, following the transaction. The revenue of the consolidated company in 2018 is expected to be at approximately $35 million.

Christopher C. Reeg, Chief Executive Officer of Fuse, said, "We are thrilled to have the CPM family join the Fuse team, and look forward to welcoming new business associates to Fuse. We are confident that the consolidated Fuse and CPM organizations will provide the necessary platform to achieve our numerous growth and expansion goals."

FXMD.OB closed Tuesday's trading at $1.50, unchanged from the previous day's close.

Medicure Inc. (MPH.V) (MCUJF.OB) announced that Carmel Biosciences Inc.'s Prexxartan oral solution has received final approval from the FDA.

Prexxartan becomes the first and only approved oral liquid dosage form of the angiotensin II receptor blocker ("ARB") Valsartan in the United States.

PREXXARTAN is indicated for the treatment of hypertension in adults and children six years and older, to lower blood pressure; heart failure (NYHA class II-IV) in patients who are unable to swallow Valsartan tablets and stable left ventricular failure or left ventricular dysfunction following myocardial infarction.

Medicure acquired an exclusive license to sell and market PREXXARTAN oral solution in the United States and its territories from Carmel Biosciences in October of this year.

Now that the final approval has been granted, Medicure intends to launch Prexxartan oral solution during the first half of 2018.

MCUJF.OB closed Tuesday's trading at $5.62, up 0.36%.

The FDA has granted accelerated approval to Pfizer Inc.'s (PFE) supplemental New Drug Application for BOSULIF to include first-line treatment of patients with chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Continued approval for the expanded indication depends upon confirmation of clinical benefit in an ongoing long-term follow up trial.

BOSULIF was approved by the FDA in September 2012 for the treatment of adult patients with Ph+ CML who are resistant to or intolerant to prior therapy.

PFE closed Tuesday's trading at $36.94, down 0.51%.

Skyline Medical Inc. (SKLN), the producer of STREAMWAY system, has agreed to purchase up to 25% equity stake in Helomics Corporation, a precision diagnostic company and integrated clinical contract research organization.

Under the terms of the agreement, Skyline Medical is purchasing preferred stock convertible into 20% of the outstanding common stock of Helomics, representing 20% of the company, in exchange for total consideration of 1.1 million shares of newly issued Skyline common stock. In addition, Skyline has the right to convert a previous $500,000 loan to Helomics into a further 5% equity stake, bringing its total ownership to 25%. The completion of the purchase is subject to listing of the shares on NASDAQ.

Skyline Medical's STREAMWAY system is an FDA-cleared direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures.

SKLN closed Tuesday's trading at $1.14, unchanged from the previous day's close. In after-hours, the stock was up 18.42% to $1.35.

Spark Therapeutics (ONCE) has received FDA approval for LUXTURNA, well ahead of the decision date of January 12, 2018.

LUXTURNA is a one-time gene therapy product indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

LUXTURNA should only be administered to patients with mutations on both copies of the RPE65 gene who have sufficient viable retinal cells as determined by their treating physicians, the Company noted.

Only selected treatment centers in the U.S. will administer LUXTURNA. This gene therapy product is expected to be available for administration in these treatment centers late in the first quarter of 2018.

LUXTURNA is currently under review with the European Medicines Agency.

ONCE closed Tuesday's trading at $48.94, down 0.22%.

TherapeuticsMD Inc.'s (TXMD) resubmitted New Drug Application for TX-004HR has been accepted for review by the FDA, with a decision expected on May 29, 2018.

TX-004HR is the Company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

The FDA had turned down the Company's request to approve TX-004HR in May of this year, citing lack of long-term endometrial safety data for the product candidate beyond the 12-weeks studied in the pivotal phase III study.

Will the second time prove a charm for TX-004HR?

If approved, the Company plans to launch TX-004HR in the third quarter of 2018.

TXMD closed Tuesday's trading at $6.17, down 6.37%. In after-hours, the stock fell another 6.81% to $5.75.