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PTIE Bleeds On FDA Snub, Starpharma Shines, FOLD Unfolds Plans, AKAO Disappoints

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Today's Daily Dose brings you news about FDA's mixed ruling on Achaogen's ZEMDRI; FDA panel recommending against approval of Pain Therapeutics' Remoxy ER; Starpharma's license agreement with Mundipharma and Amicus' regulatory and clinical development update.

Read on...

The FDA has approved Achaogen Inc.'s (AKAO) ZEMDRI (plazomicin) for only one of the two proposed indications - i.e., for treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.

However, the regulatory agency has turned down the Company's request to approve ZEMDRI for the treatment of bloodstream infection.

Issuing a Complete Response Letter for ZEMDRI for the treatment of bloodstream infection, the FDA has stated that the CARE study does not provide substantial evidence of effectiveness to approve the drug for that indication.

The CARE Trial is a phase III study based on which the Company had sought approval of ZEMDRI for the treatment of bloodstream infection.

AKAO closed Tuesday's trading at $9.59, down 20.22%.

Amicus Therapeutics (FOLD) has updated its regulatory and clinical development related to its AT-GAA for Pompe disease.

The Company is planning to commence a pivotal study of AT-GAA for Pompe disease in 2H 2018, pending feedback from the Type C meeting with FDA which is on track for 3Q18.

Also to watch out for are:

-- Data from up to 10 additional ERT-switch patients in a new Cohort 4 as part of the ongoing Phase 1/2 study, which is anticipated in 2019.
-- Presentation of longer-term clinical data out to 18-months for the 19 original Phase 1/2 patients, expected in 2H 2018.
-- Completion of a retrospective natural history study in approximately 100 ERT-treated Pompe patients, with data expected in 2H 2018.

FOLD closed Tuesday's trading at $15.49, up 0.85%.

With an FDA panel recommending against approval of investigational pain drug Remoxy ER, it is déjà vu for Pain Therapeutics Inc. (PTIE) and Durect Corp. (DRRX).

The panel has voted 14 to 3 against the approval of Remoxy ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Remoxy ER is a long-acting abuse-resistant version of oxycodone, a powerful narcotic painkiller, formulated with Durect Corp.'s (DRRX) ORADUR technology. Remoxy is bioequivalent to Purdue Pharma's Oxycontin, meaning the two drugs provide similar levels of oxycodone in people when used as intended.

The FDA's final decision on Remoxy ER is expected by August 7, 2018.

The New Drug Application for Remoxy has been rejected thrice by the FDA - i.e., in December 2008, June 2011, and September 2016.

In after-hours trading on Tuesday, PTIE was down 72% to $2.43.

Starpharma (SPHRY.OB) has licensed VivaGel BV to Mundipharma for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America.

This deal entitles Starpharma to receive an upfront fee and eligible milestones which total up to A$20.9M (US$15.5M) in addition to a financially attractive revenue share.

A license deal was signed with Mundipharma in May 2018 for Asia, the Middle East, Africa and parts of Latin America.

The total eligible milestones payable to Starpharma for all Mundipharma territories are up to A$33.3M (US$24.7M), plus revenue share.

The NDA submission for VivaGel BV for two indications, i.e., treatment and prevention of Bacterial Vaginosis (BV), was completed on April 30, 2018.

The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for VivaGel BV (for both BV indications).

Starpharma is also in advanced commercial negotiations for marketing rights to VivaGel BV in North America and expects to announce further licensing arrangements in the near future.

SPHRY.OB closed Tuesday's trading at $8.30, down 4.60%.

Xeris Pharmaceuticals Inc. (XERS) has closed its initial public offering of 6.55 million shares of common stock at a public offering price of $15.00 per share, and full exercise of underwriters' option.

The aggregate gross proceeds to the Company were approximately $98.3 million.
On June 25, 2018, the Company announced that two of its phase 3 clinical studies on its investigational ready-to-use, room-temperature stable liquid glucagon rescue pen yielded positive results.

The data highlighted the efficacy and safety of Xeris ready-to-use glucagon rescue pen in treating severe hypoglycemia in adults and children with type 1 diabetes compared to the currently marketed Glucagon Emergency Kit (GEK).

XERS touched a new intraday high of $22.26 on Tuesday, before closing the day's trading at $19.79, up 3.61%.

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