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.

MULTIPLE MYELOMA RESEARCH FOUNDATION (MMRF) FOUNDER KATHY GIUSTI TO CO-CHAIR HARVARD BUSINESS SCHOOL/KRAFT PRECISION MEDICINE ACCELERATOR

On June 13, 2016 The Multiple Myeloma Research Foundation (MMRF), a leader in precision medicine, reported that its founder, Kathy Giusti, whom Fortune recently named as one of three business leaders who are disrupting medicine, has been appointed faculty co-chair of the Kraft Precision Medicine Accelerator at Harvard Business School (HBS) (Press release, Multiple Myeloma Research Foundation, JUN 13, 2016, View Source [SID:1234513283]).

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Giusti, an alumna of HBS, will lead the Harvard Business School Kraft Precision Medicine Accelerator with HBS faculty member and co-chair Richard Hamermesh under the umbrella of the School’s Health Care Initiative. She will continue to act as a member of the MMRF Board of Directors and take an active role in the organization’s leadership.

The HBS Kraft Precision Medicine Accelerator is made possible by a $20M endowment from the Kraft Family Foundation, under the leadership of foundation President, Robert K. Kraft. The Kraft family, through its family foundation, is committed to giving back to the community. The foundation’s primary mission includes supporting education, healthcare, science, and the needs of underserved individuals.

"Precision medicine has the potential to revolutionize the way we prevent, diagnose, treat, and, ultimately, cure cancer and other devastating diseases. I look forward just as much to sharing the MMRF model as I do to learning best practices from other world-class organizations focused on this promising approach," said Ms. Giusti, who is also a multiple myeloma patient.

"The promise of precision medicine will only be realized if we abandon a siloed approach to research and work collaboratively toward a greater good – two approaches Kathy Giusti has embraced and advocated in her nearly two decades of service to the cancer community. I am certain her vision and leadership of the HBS/Kraft Precision Medicine Accelerator will greatly improve the lives of people with cancer and other diseases," said Robert Kraft.

The mission of the HBS/Kraft Precision Medicine Accelerator is to speed innovation and medical breakthroughs in precision medicine, the process by which genomic information and other unique characteristics of a person’s disease are used to predict which treatments will be most effective. The Accelerator will convene best-in-class leaders from the business, medical, scientific, and technological communities to identify and solve challenges slowing the advancement of precision medicine, disseminate best practices and models to overcome these challenges, and, ultimately, enable the faster commercialization of high-impact innovations.

"Many of the biggest challenges in advancing breakthroughs promised by precision medicine are business challenges—how to best develop and commercialize medical solutions for public benefit, and how to optimally share data, for example. HBS is uniquely positioned to address these challenges by drawing on the ingenuity and expertise of our faculty, alumni, and students, and by convening the leaders who can develop innovative new models," said HBS Dean Nitin Nohria.

MabVax Therapeutics Launches Second Investigational Site with Sarah Cannon Research Institute in Ongoing Phase I Clinical Trial to Evaluate New Treatment for Pancreatic Cancer

On June 13, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the initiation of a second investigational Phase I site for MVT-5873 (HuMab-5B1) with Sarah Cannon Research Institute through its network of research sites (Press release, MabVax, JUN 13, 2016, View Source [SID:1234513257]). The product is for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. In addition to the Sarah Cannon Research Institute at Tennessee Oncology site in Nashville, Tenn., patient enrollment in the Phase I trial is underway within Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, Fla.

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The Phase I trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard-of-care chemotherapy regimen in patients with metastatic pancreatic cancer. The first group of patients are being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient group will establish the safety and recommended dose of the antibody when administered with standard-of-care chemotherapy. Lead investigators at Sarah Cannon’s research sites are Todd M. Bauer, MD, associate director of drug development in Nashville, and Judy Wang, MD, associate director of drug development in Sarasota.

"We are very excited to engage with Sarah Cannon’s world-class clinical research organization and are highly encouraged by progress with patient enrollment to date," said David Hansen, MabVax President and CEO. "Pancreatic cancer is very difficult to treat and patients with advanced disease have few therapeutic options. We are delighted to be working with site staff at these research sites to evaluate MVT-5873 as a potential new therapeutic option for these patients."

About HuMab-5B1:

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

Onconova Presents Clinical Data from Oral Rigosertib and Azacitidine Combination Study in Higher-Risk Myelodysplastic Syndromes at EHA Annual Meeting

On June 13, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the presentation of data by Onconova collaborators from the U.S. and Europe from the ongoing Phase 2 clinical trial of oral rigosertib in combination with azacitidine in patients with either first- or second-line higher-risk myelodysplastic syndromes (HR-MDS) at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark, which took place June 9 — 11, 2016 (Press release, Onconova, JUN 13, 2016, View Source [SID:1234513246]).

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The results of this study are being finalized to initiate end of Phase 2 discussions with U.S. and European regulatory agencies to define the next steps in the development plan for this combination therapy. These interim results were initially presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2015.

"We are encouraged by the interim overall response rate results of this Phase 2 trial, which demonstrated that 23 of 30 patients, or 77%, responded to treatment, and anticipate further updates to the data set," stated Steve Fruchtman, M.D., Chief Medical Officer of Onconova. "Of note, 84% of HMA-naïve patients responded to this novel combination. We look forward to discussing these results, and the longer-term follow-up from this study, with U.S. and European regulatory agencies in order to define the next step of development for this combination therapy."

A full copy of the EHA (Free EHA Whitepaper) poster entitled, "Results from Phase I/II Study of the Combination of Oral Rigosertib and Azacitidine in Patients with Myelodysplastic Syndromes (MDS)," may be accessed by visiting "Posters" in the Investors and Media section of Onconova’s website at www.onconova.com.

Sunesis Pharmaceuticals Announces Presentation of Positive Results from MD Anderson Sponsored Trial in Frontline Elderly AML and MDS at the EHA Annual Meeting

On June 13, 2016 Sunesis Pharmaceuticals (NASDAQ:SNSS) reported the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) (Press release, Sunesis, JUN 13, 2016, View Source;p=RssLanding&cat=news&id=2177015 [SID:1234513244]). The results were presented Saturday in an oral session titled "New Compounds in AML Treatment" at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark. The presentation (abstract S505, Bella Center, Hall A3), titled "Phase I/ll study of vosaroxin and decitabine in newly diagnosed older patients with acute myeloid leukemia and high-risk myelodysplastic syndrome," is available at www.sunesis.com.

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"Older patients diagnosed with AML and MDS have limited treatment options and exceedingly poor outcomes," said Naval Daver, M.D., Assistant Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a study investigator. "At the optimized induction dose of 70 mg/m2 of vosaroxin, the combination of vosaroxin and decitabine demonstrates a compelling CR/CRp/CRi rate of 76% and a median overall survival of 16.1 months. This response rate and survival are significantly better than seen with single-agent decitabine among similar patients at our institution. This outcome was achieved with <5% induction mortality and good tolerability. In this vosaroxin-decitabine cohort, 23 of 41 patients remain alive."

Daniel Swisher, CEO of Sunesis, added: "We believe these results warrant further exploration in a larger outcome study, with plans currently under review to conduct a multicenter clinical trial comparing vosaroxin plus decitabine and vosaroxin plus cytarabine to the 7+3 regimen in patients with AML."

To date, 63 patients (56 AML, 7 high-risk MDS) with a median age of 69 years (range 60-78) have been enrolled in the trial. All 63 patients have completed at least 2 treatment rounds, rendering them evaluable for response; with a 75% overall response rate, 49% (31 patients) achieved complete remission (CR), 17% (11 patients) achieved CR with incomplete platelet recovery (CRp), and 8% (5 patients) achieved CR with incomplete peripheral blood count recovery (CRi). The therapy was well-tolerated, with the main therapy related grade 3 or higher toxicities being mucositis in 11 (17%) patients.

Initially for the first 22 patients in the study, the selected induction dose of vosaroxin was 90 mg/m2. Thereafter to reduce the incidence of mucositis, the induction dose was reduced to 70 mg/m2 for the next 41 patients. The lower dose of vosaroxin in combination with decitabine was associated with reduced early mortality and an improved overall response rate and OS, as follows:

Induction
Dose
(vosaroxin) N Median
OS 8-week
Mortality Overall
Response Need >1 Cycle to
Response
90 mg/m2 22 5.5 27 % 73 % 19 %
70 mg/m2 41 16.1 5 % 76 % 42 %

Sunesis also announced that follow-up data from the company’s VALOR trial was presented as an e-poster during the EHA (Free EHA Whitepaper) meeting. The poster (abstract E930, Bella Center, E-Poster Screens), titled "Characterization of patients with relapsed or refractory AML in continued follow-up after treatment with vosaroxin/cytarabine vs placebo/cytarabine in the VALOR trial," shows that, as of January 22, 2016, 83 of 711 patients enrolled in VALOR remain alive (46/356 in the vosaroxin/cytarabine arm, 37/355 in the placebo/cytarabine arm) and in follow up, which has reached a median of 40 months. In patients ≥60 years, more than twice as many patients were alive in the vosaroxin/cytarabine arm (23 vs. 10 patients).

All but seven patients in this follow up underwent allogeneic hematopoietic stem cell transplant (HCT). Of note, the non-HCT survivors were all in the vosaroxin/cytarabine treatment arm (68-71 years old, 2 primary refractory and 5 early relapsed).

Mr. Swisher added: "We are encouraged by the long-term benefit seen in the VALOR follow-up and also the potential for vosaroxin and cytarabine to provide long-term benefit in older patients who need more options."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.