It's Raining FDA Approvals, SMMT Opens Wallet, AGRX Snubbed Yet Again

(RTTNews) - Today's Daily Dose brings you news about approval of the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness; approval of MRK/PFE's Type 2 diabetes drugs; delay in FDA's action on Portola's Biologics License Application for AndexXa; Summit's acquisition of a next generation targeted antimicrobials company; an update on Ocular's Dextenza and Agile's disappointment over hormonal contraceptive patch Twirla.

Read on...

Shares of Agile Therapeutics Inc. (AGRX) plunged over 47% on Friday after the Company's investigational low-dose combined hormonal contraceptive patch Twirla was turned down by the FDA yet again.

In its Complete Response Letter, the FDA has raised concerns of deficiencies relating to quality adhesion test methods, deficiencies in a facility of the Company's third-party manufacturer, Corium International Inc. (CORI), for Twirla, and the in vivo adhesion properties of Twirla and their potential relationship to the SECURE phase 3 clinical trial results.

Twirla was rejected by the FDA in 2013 too, and the Company was asked to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.

Al Altomari, chairman and CEO of Agile Therapeutics, said, "We are clearly disappointed, and we are evaluating the FDA's response. We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and discuss a path to approval for Twirla. We will work closely with the FDA to address the points raised in the CRL as quickly as possible."

AGRX touched a new low of $1.93 on Friday before closing the day's trading at $2.52, down 47.06%.

The FDA decision date on BioMarin Pharmaceutical Inc.'s (BMRN) Pegvaliase Biologics License Application has now been extended by three months to May 28, 2018.

Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase enzyme product, proposed to reduce blood phenylalanine (Phe) levels in adult patients with phenylketonuria (PKU) who have uncontrolled blood Phe levels on existing management.

The Pegvaliase BLA was originally assigned a decision date of February 28, 2018.

BMRN closed Friday's trading at $90.46, down 1.19%.

The FDA has approved Merck (MRK) and Pfizer Inc.'s (PFE) three new drugs - Ertugliflozin under brand name STEGLATRO; a fixed dose combination of Ertugliflozin and Januvia, under brand name STEGLUJAN, and a fixed dose combination of Ertugliflozin and Metformin under brand name SEGLUROMET, for adults with Type 2 diabetes.

Januvia and Metformin are already approved drugs of Merck for type 2 diabetes mellitus.

STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both STEGLATRO and Januvia is appropriate.

SEGLUROMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing STEGLATRO or metformin, or in patients who are already treated with both STEGLATRO and metformin.

STEGLATRO is available in 5 mg and 15 mg tablets. STEGLUJAN combines 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin. SEGLUROMET combines 2.5 mg or 7.5 mg of ertugliflozin with 500 mg or 1,000 mg of metformin hydrochloride, and sports a boxed warning for lactic acidosis, according to the companies.

MRK closed Friday's trading at $56.36, down 0.42%.

The Securities and Exchange Commission has issued a subpoena to Ocular Therapeutix Inc. (OCUL) for information tied to the Company's DEXTENZA 0.4mg, including related communications with the FDA, investors and others.

Dextenza is an investigational intracanalicular depot corticosteroid formulation designed to deliver sustained release dexamethasone to the surface of the eye over an extended period for the treatment of post-surgical ocular inflammation and pain.

The FDA declined to approve Dextenza in July of this year, citing deficiencies in manufacturing processes and analytical testing related to manufacture of Dextenza for commercial production.

Class action lawsuits have been filed alleging that the Company failed to disclose in relevant times that it was experiencing significant manufacturing issues with respect to DEXTENZA.

OCUL closed Friday's trading at $4.58, down 0.65%.

The FDA has pushed back the decision date on Portola Pharmaceuticals Inc.'s (PTLA) Biologics License Application for AndexXa to May 4, 2018 from February 3, 2018.

AndexXa is designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors.

Factor Xa inhibitors are anticoagulants used to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. One of the major complications of treatment with Factor Xa inhibitors is bleeding.

AndexXa was rejected by the FDA last year, and the Company was asked to provide additional information primarily related to manufacturing, among other things.

The Company's resubmitted Biologics License Application for AndexXa was accepted for review by the FDA in August of this year, and a decision date was originally set for February 3, 2018. But with the Company recently submitting additional data to the FDA, the decision date on AndexXa has been extended.

AndexXa is also under review in the European Union. A final decision by the European Commission is anticipated in the first half of 2018.

PTLA closed Friday's trading at $54.86, up 1.72%.

Sinovac Biotech Ltd. (SVA) has received a positive decision from the World Health Organization on the acceptability of the Company's hepatitis A vaccine Healive for purchase by United Nations agencies.

Healive is approved for use in China. The Company noted that the positive decision from the WHO will provide opportunities to accelerate the regulatory approval process for the vaccine in international countries outside China.

SVA closed Friday's trading at $7.93, down 0.50%.

Summit Therapeutics plc (SMMT) has acquired Discuva Ltd., a privately held UK-based company for £10.0 million, positioning the Company as a leader in Research & Development of new classes of antibiotics.

Discuva's principal asset is a genetics-based technology platform for the generation of antibiotics. The acquisition expands Summit's interests in infectious diseases that are led by its flagship antibiotic candidate Ridinilazole, for the treatment of Clostridium difficile infection, which has completed phase II testing.

The purchase price comprised of £5.0 million in cash and £5.0 million in new ordinary shares of Summit of one penny nominal value issued to Discuva shareholders at a price of 170.4 pence per share, representing a 3.3% premium to Summit's mid-market closing share price on 22 December 2017.

Discuva already has a collaboration agreement with Roche. Roche is obligated to pay specified development, commercialisation and sales milestone payments related to any compound developed under the platform that is or has been optioned by Roche. Now that Discuva has been acquired, Summit is obligated to pay to Discuva shareholders one-half of the economic benefit of any such payments received from Roche.

Another product candidate in Summit's pipeline is Ezutromid, under phase II trial in patients with Duchenne muscular dystrophy, called PhaseOut DMD.

PhaseOut DMD is a 48-week trial that has enrolled 40 patients at sites in the UK and the U.S.

Near-term catalysts:

-- Report 24-week data from the PhaseOut DMD trial in Q1, 2018. -- Report 48-week data from the PhaseOut DMD trial in Q3, 2018.

SMMT closed Friday's trading at $10.80, up 2.08%.

The FDA has approved Bausch + Lomb's LUMIFY, previously known as Luminesse, as the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness.

Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (VRX) (VRX.TO), licensed LUMIFY from privately held Eye Therapies Inc.

Brimonidine, which was first approved by the FDA in 1996 for intraocular pressure (IOP) reduction in glaucoma patients, is available at higher doses in prescription eye care products.

LUMIFY is expected to be available for purchase in major retailers in the second quarter of 2018.

VRX closed Friday's trading at $21.55, down 0.55%.