==Amicus Therapeutics (FOLD) has entered into a License Agreement with Teva Pharmaceuticals (TEVA)

 

Amicus Therapeutics has entered into a License Agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc.

• This Agreement resolves the patent litigation brought by Amicus in response to Teva's Abbreviated New Drug Application seeking approval to market a generic version of GALAFOLD 123mg capsules prior to expiration of the applicable patents.
• Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration and unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo1 as the remaining active party and the litigation stay remains in place for Lupin.
  
• As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

Unusual Options Activity Fri 10/13/23

The following options are exhibiting notable trading, potentially indicating changing sentiment toward the underlying stocks, and/or potentially representing positioning for increased volatility.

Bullish Call Activity:

• FOLD Jan24 12 calls (volume: 20.0K, open int: 10, implied vol: ~66%, prev day implied vol: 52%). Co is expected to report earnings early November.
• PBR Nov 15 calls (volume: 34.6K, open int: 450, implied vol: ~40%, prev day implied vol: 38%). 3890 contracts traded in a single transaction. Stock was upgraded to Buy from Hold at HSBC Securities. Co is expected to report earnings late October.
• SE Dec 65 calls (volume: 5570, open int: 20, implied vol: ~70%, prev day implied vol: 68%). 3700 contracts traded in a single transaction. Co is expected to report earnings mid-November.
  

Bearish Put Activity:

• GPRE Oct 25 puts (volume: 2410, open int: 0, implied vol: ~67%, prev day implied vol: 53%). Co is expected to report earnings early November.
• SOFI Oct 8.5 puts (volume: 1080, open int: 1750, implied vol: ~61%, prev day implied vol: 58%). Co is confirmed to report earnings October 30 before the open.
  

Sentiment: The CBOE Put/Call ratio is currently: 0.94, VIX: (13.60, +0.98, +1.0%).
October 20 is options expiration -- the last day to trade October equity options.

=Amicus Therapeutics (FOLD) to re-file for rare disease drug

• The Food & Drug Administration confirmed the company's plans to submit a new drug application for Amicus' migalastat, an oral treatment for Fabry disease. The company expects to submit during the fourth quarter. 
• The FDA could still reject the drug.

Last November,  tiny Amicus Therapeutics said that the Food and Drug Administration would not even consider approving migalastat, a treatment for a rare disorder called Fabry disease, until more data were collected, a process that was expected to take until 2019 or 2020.

Today, Amicus says that the FDA is reversing the decision, and that there is a clear path to approval.  Amicus hopes to file a new drug application by the end of the year, and approval would take six months after that. That will shave three or four years off the drug's path to market if all goes well.

In Fabry disease, a substance called GL-3 builds up in the body, causing pain, kidney failure, heart disease and stroke. About 3,000 Americans have been diagnosed with the condition, according to Amicus. Migalastat is thought to work only in about half the patients with the disease, whose disorder is linked to certain genetic mutations.

The drug was approved in the European Union a year ago, but the FDA was declining to consider Amicus' application, in part because one of two clinical trials of the drug had failed to meet its main prespecified goal. But John Crowley, Amicus' chief executive, says that the company convinced the FDA to look at its data using new analyses, including some that had been asked for by European regulators, and patient testimony. "We didn’t ask them to lower the bar," he says. "We just asked them to review the existing data."

Crowley is famous in biotech circles for his work developing a drug for Pompe disease, another rare disease from which his daughter, Megan, suffers. The story was the subject of a book, The Cure, and a movie, Extraordinary Measures, which starred Harrison Ford. Earlier this year, President Donald Trump highlighted Megan Crowley's story in a speech to congress as an example of the need for a more flexible FDA.

=Amicus Therapeutics (FOLD) reported earnings on Wed 1 March 17 (b/o)

When Amicus Therapeutics Inc. (FOLD) company posted a net loss of $1.49 per share on $5.0 million in revenue. This fell short consensus estimates from Thomson Reuters that called for a net loss of $1.40 per share and $5.86 million in revenue. However, there were more redeeming factors in the report.

John F. Crowley, board chair and chief executive of Amicus, commented:

Throughout 2016 we made significant progress with the international launch of our first commercial product Galafold and continued to advance and expand our robust pipeline of first- and/or best-in-class medicines for people living with devastating rare diseases. During 2017 we are laser focused on five key strategic priorities to advance our vision to develop and deliver great medicines for patients and to create significant shareholder value: 1) advancing the international launch of Galafold for Fabry disease, 2) completing our regulatory submission for migalastat in Japan (J-NDA), 3) establishing our novel Pompe treatment paradigm ATB200/AT2221 as a highly differentiated therapy, 4) successfully completing our Phase 3 clinical study in patients with epidermolysis bullosa, and 5) maintaining our financial strength. With one commercial-stage medicine and two medicines in clinical development, as well as a biologics platform for future growth, we are building a leading global biotechnology company focused on delivering meaningful benefits for patients living with devastating rare diseases.

Cash, cash equivalents and marketable securities totaled $330.4 million at the end of the quarter, compared to $214.0 million last year.