GlycoMimetics’ GMI-1271 Receives FDA Fast Track Designation for Treatment of Acute Myeloid Leukemia

On June 13, 2016 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel E-selectin antagonist GMI-1271 for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and elderly patients aged 60 years or older with AML (Press release, GlycoMimetics, JUN 13, 2016, View Source [SID1234617424]).

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"We believe GMI-1271 has the potential to address important unmet needs for individuals with relapsed or refractory AML, as well as for older AML patients, for whom the standard of care often fails to provide outcomes as positive as those seen in other patient groups," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "The FDA’s granting of a Fast Track designation for GMI-1271 to treat AML is an important step in advancing this drug candidate through the regulatory process, and if successful, in bringing a novel drug to patients in an expedited time frame."

The Fast Track Designation is designed to facilitate development and expedite review of experimental therapies that address the unmet medical needs of patients with serious conditions.

AML is a cancer of immature white blood cells that starts in the bone marrow but can quickly spread into the blood, lymph nodes, liver, spleen, central nervous system, and testicles. Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society. Chemotherapeutic methods among patients with refractory and relapsed AML have low remission rates, between 25 and 30 percent.

GlycoMimetics announced on Friday, June 10, presentation of data from the Phase 1 portion of its on-going Phase 1/ 2 clinical trial testing GMI-1271 combined with induction chemotherapy, in patients with relapsed/refractory acute myeloid leukemia (AML). Data was reported at the European Hematology Association (EHA) (Free EHA Whitepaper)21stCongress in Copenhagen, Denmark in a poster entitled "Results of a Phase 1 study of GMI-1271, a potent E-selectin antagonist in combination with induction chemotherapy in relapsed/refractory AML: a novel, well-tolerated regimen with a high remission rate."

In addition, GlycoMimetics recently announced that the first patient with relapsed or refractory AML has been dosed in the company’s Phase 2 portion of the ongoing Phase 1/2 clinical trial of GMI-1271. This clinical trial is a multinational open-label study evaluating endpoints for safety, pharmacokinetics (PK) and efficacy of GMI-1271 in combination with induction chemotherapy in patients with high-risk AML. This trial is being conducted at a number of academic medical institutions in the United States, Ireland, and Australia. While the primary objective is to assess safety, additional endpoints include overall response rate, biomarkers of activity, durability of response and overall survival. The Phase 2 portion of the study is expected to include approximately 25 participants with relapsed or refractory AML and approximately 25 participants who are newly diagnosed.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with AML cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

Alligator presents at Småbolagsdagen in Stockholm

On June 13, 2016 Alligator presented the corporate presentation (Presentation, Alligator Bioscience, JUN 13, 2016, View Source [SID1234538699]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Perrigo Confirms First To File Patent Challenge For Generic Version Of Picato® Gel (0.015% And 0.05%)

On June 13, 2016 Perrigo Company plc (NYSE: PRGO; TASE) reported that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%), the generic versions of Picato gel (0.015% and 0.05%) (Press release, Perrigo Company, JUN 13, 2016, View Source [SID:1234514915]). Perrigo has notified Leo Pharma A/S and Leo Laboratories, Ltd., the owners of the New Drug Applications (NDAs) and patents listed in FDA’s Orange Book, of its filings.

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On June 10, 2016, Leo Pharma A/S, Leo Laboratories Limited and Leo Pharma, Inc. filed suit in the United States District Court for the District of Delaware alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, making it eligible for 180 days of generic exclusivity.

Picato gel (ingenol mebutate gel) is a prescription medicine indicated for the topical treatment of actinic keratosis. Branded sales for the twelve months ending April 2016 were approximately $69 million.

Perrigo’s CEO John T. Hendrickson stated, "This filing illustrates Perrigo’s commitment to providing Quality Affordable Healthcare Products. The Rx team continues to invest in the development of important products that strengthen our extended topicals portfolio and drive savings for our customers and consumers."

SANOFI FILES DEFINITIVE CONSENT SOLICITATION TO REMOVE AND REPLACE MEDIVATION’S BOARD

On June 13, 2016 Sanofi reported that it has filed definitive consent solicitation materials with the U.S. Securities and Exchange Commission ("SEC") seeking to remove and replace each member of Medivation, Inc.’s (NASDAQ: MDVN) Board of Directors with eight independent and highly-qualified candidates (Press release, Sanofi, JUN 13, 2016, View Source [SID:1234513296]). Sanofi’s nominees are committed to fully and fairly evaluating all of Medivation’s strategic options, including Sanofi’s acquisition offer, in accordance with their fiduciary duties to Medivation and its shareholders.

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Sanofi is mailing a letter to Medivation’s shareholders along with the definitive consent solicitation statement, which includes a WHITE consent card, providing Medivation shareholders the ability to demonstrate support for a transaction.

"We have had extensive conversations with Medivation shareholders and believe that there is overwhelming support for Medivation to undertake a sale process that includes Sanofi," said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. "We have been clear that if Medivation were to engage and provide information, we would be in a position to increase our offer and are confident that we would be able to offer significant additional value. Medivation’s continued refusal to substantively engage beyond its continued rejection underscores that the current Board is not acting, and will not act, in the best interests of Medivation shareholders. We urge all Medivation shareholders to support Sanofi’s efforts to elect directors that are committed to maximizing value."

The letter being mailed to Medivation shareholders with Sanofi’s definitive solicitation statement reads as follows:
MEDIVATION’S CONTINUED REFUSAL TO SUBSTANTIVELY ENGAGE WITH SANOFI, BEYOND ITS CONTINUED REJECTION, IS DENYING SHAREHOLDERS THE OPPORTUNITY TO REALIZE SIGNIFICANT, IMMEDIATE AND CERTAIN VALUE

ELECT DIRECTORS COMMITTED TO MAXIMIZING VALUE FOR MEDIVATION SHAREHOLDERS

SIGN, DATE AND RETURN THE "WHITE" CONSENT CARD TODAY

Dear Medivation Shareholder:
We are sending you the enclosed Consent Statement and accompanying WHITE consent card to enable you, Medivation’s shareholders, to act in your best financial interests by removing and replacing the current Medivation board of directors with eight independent and highly-qualified candidates.

We believe that the current Medivation board of directors is not acting, and will not act, in your best interests. Our belief is supported by the current Medivation board of directors’ consistent refusal to substantively engage, beyond its continued rejection, with Sanofi on our all-cash offer to acquire Medivation for $52.50 per share of Common Stock. This is all the more concerning given that we have been very clear that Sanofi would be in a position to increase our offer and we are confident that we will be able to offer significant additional value if Medivation were to engage and provide information.

SANOFI’S COMPELLING OFFER demaNDs SUBSTANTIVE ENGAGEMENT BEYOND CONTINUED REJECTION FROM THE MEDIVATION BOARD

On March 25, 2016 and April 3, 2016, Sanofi privately approached Medivation expressing our interest in negotiating a mutually beneficial transaction. In both instances, Medivation informed us that it was not interested in discussing a potential transaction. On April 15, 2016, Sanofi submitted a private proposal to Medivation to acquire all of the outstanding shares of Medivation for $52.50 per share in cash, representing over a 50 percent premium to Medivation’s two-month volume weighted average price prior to there being takeover rumors.

On April 28, 2016, Sanofi made its proposal public as a result of the Medivation Board’s refusal to engage, beyond its rejection. Then, without any significant discussions with Sanofi, the Medivation board of directors rejected Sanofi’s proposal and has consistently refused to substantively engage in any discussions or negotiations, beyond its continued rejection. Sanofi also advised Medivation, and disclosed publicly, that we were – and remain – willing to enter into a confidentiality agreement with Medivation, which would include a reasonable standstill for Medivation to conduct a sale process. As a testament to our good faith efforts to advance discussions with Medivation, Sanofi sent a proposed Confidentially Agreement to Medivation on May 30, 2016, which included a reasonable standstill to give time for Medivation to conduct a sale process. Despite these efforts, Medivation remains unwilling to substantively engage, beyond its continued rejection, and has only offered information already known to the market to justify its refusal to enter negotiations.

Medivation SHAREholders Deserve to Be Heard

Since Sanofi publicly disclosed our proposal to acquire Medivation, we have had extensive conversations with many of you and other Medivation shareholders. Based on our conversations, we believe that you overwhelmingly support the sale of Medivation and want the Medivation board to undertake a sale process and substantively engage with Sanofi, beyond its continued rejection.

We believe Medivation’s refusal to announce a sale process or substantively engage with Sanofi, beyond its continued rejection, underscores that the current Medivation Board is not listening to shareholders and not acting in your best interests.

VOTE TO ELECT DIRECTORS WHO ARE COMMITTED TO MAXIMIZING VALUE FOR MEDIVATION SHAREHOLDERS

Accordingly, we believe that the only way to protect Medivation shareholders is to replace Medivation’s directors with eight independent, well-experienced candidates who are willing to fully and fairly evaluate all of Medivation’s strategic options, in accordance with their fiduciary duties to you and Medivation. Sanofi is seeking your support for the election of eight independent and highly-qualified candidates. If the Nominees are elected, we intend to continue to pursue our acquisition proposal and hope that the new Medivation Board will fully and fairly evaluate all of Medivation’s strategic options, including Sanofi’s acquisition offer, in accordance with their fiduciary responsibilities.

We believe that our candidates are highly-qualified to serve as directors of Medivation and are
well-respected members of the business community with extensive business, public company and/or healthcare experience. Importantly, these individuals are committed to acting in the best interests of Medivation and its shareholders and have the necessary track-record, strategic vision and experience to maximize shareholder value. We believe that, if elected, each of our candidates would be considered an independent director of Medivation and will exercise his or her independent judgment in all matters that come before the Medivation board of directors.

Protect Your Investment and act promptly to sign
and return the white consent card TODAY

We urge you to demonstrate your support for a transaction and consent to the proposals set forth in this consent statement, including electing each of the independent candidates nominated by Sanofi. Please sign, date and return the enclosed WHITE consent card in the postage-paid envelope provided as soon as possible.

We also urge you not to revoke your consent by signing any consent revocation card sent to you by Medivation. You have every right to revoke any consent revocation you may have already submitted to Medivation. To revoke an earlier revocation and change your vote, simply consent to the proposals set forth in this consent statement by following the instructions on the WHITE consent card.

Remember, if your shares of Medivation common stock are held through a brokerage firm, bank or other nominee, only this entity can execute a consent representing your shares and only upon receipt of your specific instructions. Accordingly, it is critical that you promptly follow the instructions included in the materials that you have received or contact the person responsible for your account and give instructions to consent to the proposals, including the election of the independent and highly qualified candidates nominated by us, on your behalf.

If you have any questions about executing or delivering your WHITE consent card or require assistance, please contact our consent solicitor, Innisfree M&A Incorporated, toll-free at (877) 750-5837.

Very truly yours,
Olivier Brandicourt
Chief Executive Officer
Sanofi

For Sanofi’s proposals in the consent solicitation to become effective, written consents would need to be properly completed by the holders of a majority of Medivation shares outstanding as of the close of business on June 1, 2016. In order to ensure that your consent is delivered to Medivation in a timely manner, we have set July 25, 2016 as the deadline for submission of written consents, but Sanofi reserves the right, in its sole discretion, to extend such deadline.

About Sanofi’s Nominees
On May 25, 2016, Sanofi named its slate of highly qualified directors, which includes Michael E. Campbell, Barbara Deptula, Wendy E. Lane, Ronald S. Rolfe, Steven J. Shulman, Charles P. Slacik, James L. Tyree and David A. Wilson.
Additional information regarding the nominees is available on the Investor Relations section of Sanofi’s website at View Source or Sanofi Files Consent Solicitation to Remove and Replace Medivation’s Board.