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Agenus Announces Lead Product Candidate Selection in its Collaboration with Merck

On June 9, 2016 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing antibodies including checkpoint inhibitors and other checkpoint modulators (CPMs) and cancer vaccines, reported the selection of a lead product candidate under its license and research collaboration with Merck (Press release, Agenus, JUN 9, 2016, View Source [SID:1234513159]).

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Merck, known as MSD outside the United States and Canada, has selected a lead antibody candidate and several backup antibodies, discovered by Agenus, to an undisclosed Merck checkpoint target. Based on this milestone and under the terms of the agreement, Agenus received a $2 million milestone payment from Merck.

As previously announced, Merck will be responsible for all future product development expenses for the selected antibody candidate and Agenus is eligible to receive up to $100 million in milestone payments, as well as royalties on worldwide product sales.

"We are pleased that in collaboration with Merck scientists, our research team has successfully identified antibody candidates to advance into preclinical studies," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This is an important validation of our discovery platform and expertise and adds to our successes in discovering antibodies for a broad range of targets, including challenging ones."

"Our integrated monoclonal antibody discovery platforms have successfully identified unique antibodies for a wide range of therapeutic targets," said Robert B. Stein, M.D., Ph.D., Agenus’ President, Research & Development. "This discovery engine provides Agenus the opportunity to bring innovative single-agent and combination immuno-oncology therapies to patients whose cancers are not adequately treated with current approaches."

New data demonstrates Sandoz’ etanercept and rituximab biosimilar candidates bioequivalent to originator products

On June 9, 2016 Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, reported results from two key studies comparing its biosimilar etanercept and rituximab candidates with the originator products – Enbrel*** and MabThera**** respectively (Press release, Novartis, JUN 9, 2016, View Source [SID:1234513158]). In both studies, the primary endpoints of achieving PK bioequivalence were met. The studies were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.[1],[2] Etanercept and rituximab are indicated to treat autoimmune diseases such as rheumatoid arthritis. Rituximab is also indicated to treat hematological cancers like follicular lymphoma.

"Findings from these studies, along with additional data in our development programs, demonstrate that our biosimilar etanercept and rituximab candidates are highly similar to their originators," said Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz. "Access to biological therapies remains a challenge for many patients with immunological disorders such as rheumatoid arthritis and blood cancers like follicular lymphoma. If approved, our biosimilars could help broaden access to these vital therapies."

The Phase I etanercept trial demonstrated PK bioequivalence and no clinically meaningful differences in safety, tolerability and immunogenicity between the biosimilar candidate and the etanercept originator product (Enbrel).[1] No major safety signals were observed during the study.[1]

The Phase II rituximab trial demonstrated PK bioequivalence and similar PD, safety, efficacy and immunogenicity between the biosimilar candidate and the rituximab originator product (MabThera).[2] Adverse events related to both products were similar for both medicines.[2]

Sandoz’ biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.

Its biosimilar rituximab candidate was accepted by the EMA for regulatory review in May 2016. Sandoz is seeking approval for the same indications as the reference product with the same presentations which is used to treat autoimmune diseases such as rheumatoid arthritis as well as a number of hematological cancers.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Sandoz has a leading biosimilar pipeline and plans to make 10 regulatory filings over a three-year period (2015-2017), having already submitted six and had one approved. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

About the Phase I etanercept study
(Annual European Congress of Rheumatology (EULAR 2016) ref: THU0145)
This study was a randomized, two-way crossover trial comparing the PK and safety of Sandoz’ biosimilar etanercept candidate with originator etanercept (Enbrel) in 54 healthy subjects, with a washout period of at least 35 days between administration of the two study drugs.[1] Follow-up was undertaken for four weeks after the final study drug administration.[1]

About the Phase II rituximab study
(Annual European Congress of Rheumatology (EULAR 2016) ref: FRI0222)
This was a prospective, randomized, double blind study in 173 patients with active rheumatoid arthritis not responsive to conventional therapies (disease-modifying antirheumatic drugs or TNF inhibitors).[2] Primary analysis was performed at week 24 with efficacy and PD data collected to week 52, with safety follow-up ending 24 weeks after the last administration of study medication.[2]

AstraZeneca enters commercialisation agreement with Aspen for anaesthetic medicines portfolio

On June 8, 2016 AstraZeneca reported it has entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for rights to its global anaesthetics portfolio outside the US (Press release, AstraZeneca, JUN 8, 2016, View Source [SID:1234513247]). The agreement covers seven established medicines – Diprivan (general anaesthesia), EMLA (topical anaesthetic) and five local anaesthetics (Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest).

Under the terms of the agreement, AGI will acquire the commercialisation rights, outside the US, to AstraZeneca’s portfolio of anaesthetic medicines for an upfront consideration of $520 million. Additionally, AGI will pay AstraZeneca up to $250 million in a Product Sales-related payment, as well as double-digit percentage trademark royalties on Product Sales. AstraZeneca will manufacture and supply the products on a cost plus basis to AGI for an initial period of 10 years. Upon completion, Aspen will assume responsibility for all activities relating to the sale of the portfolio in all relevant markets.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "AstraZeneca has a rich heritage in anaesthetic medicines and this agreement will extend the reach of our established portfolio to a greater number of patients through AGI’s extensive commercial network. This agreement supports our strategic focus on the new medicines in three main therapy areas."

Stephen Saad, Group Chief Executive, Aspen, said: "This is a strategically-important investment for AGI and it is pleasing to have a company such as AstraZeneca recognise Aspen’s commercial competencies. This transaction is an excellent opportunity to build on the quality brands commercialised through AGI, working alongside an acknowledged pioneer and leader in the field of anaesthetics."

AstraZeneca’s portfolio of anaesthetics is available in over a hundred countries worldwide, including key markets such as China, Japan, Australia and Brazil. The portfolio continues to generate stable revenue, with global Product Sales in 2015 of $592 million. The US rights to the products were divested to Abraxis, now part of Fresenius Kabi, in 2006.

Financial considerations

The transaction is subject to customary closing conditions and is anticipated to complete in the third quarter of 2016. AstraZeneca will retain a significant ongoing interest in the anaesthetics portfolio through ongoing milestone and royalty payments and the manufacture and supply of the products to Aspen. The upfront and milestone payments, as well as royalty receipts, which are open-ended, will therefore be reported as Externalisation Revenue in the Company’s financial statements. The agreement will not impact the Company’s financial guidance for 2016.

8-K – Current report

On June 8, 2016, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc. ("Spectrum"), Allos Therapeutics Inc. (the "Company"), and Sandoz Inc. ("Sandoz"), reported that they have entered into a settlement agreement to resolve their patent litigation relating to Folotyn (pralatrexate injection) (Filing, 8-K, Spectrum Pharmaceuticals, JUN 8, 2016, View Source [SID:1234513243]). As a result of the settlement, Sandoz will be permitted to market a generic version of Folotyn in the United States on November 15, 2022 or earlier under certain circumstances. Details of the settlement are confidential, and the parties will submit the agreement to the Federal Trade Commission and the Department of Justice. The parties will request that the court enter an order, in which it will dismiss the Company’s litigation against Sandoz. As previously reported, the Company has also settled the litigation against Teva Pharmaceuticals USA, Inc. and Dr. Reddy’s Laboratories, Ltd. & Dr. Reddy’s Laboratories, Inc. The Company’s litigation against one other generic filer continues. This litigation is described in further detail in Part II, Item 1 of Spectrum’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the U.S. Securities and Exchange Commission on May 6, 2016.

Sanofi Files Investor Presentation Regarding Proposed Acquisition of Medivation

On June 8, 2016 Sanofi today reported that it has filed an investor presentation with the U.S. Securities and Exchange Commission ("SEC") in connection with its proposed acquisition of Medivation, Inc. (NASDAQ: MDVN) (Press release, Sanofi, JUN 8, 2016, View Source [SID:1234513242]). This presentation is available on the Investor Relations section of Sanofi’s website.

Among other things, the presentation notes:
The proposed transaction would provide compelling strategic and financial benefits for Sanofi and Medivation shareholders;

Sanofi’s proposal is not subject to any financing condition and the company is confident in its ability to receive all necessary regulatory approvals;

Combining with Medivation would accelerate Sanofi’s strategic priority of rebuilding a competitive position in oncology;

Sanofi has stated on several occasions that if Medivation were to engage and provide information, it would be in a position to increase its offer and is confident that it would be able to offer significant additional value;

Sanofi is willing to enter into a customary confidentiality agreement with Medivation, which would include a reasonable standstill to give time for Medivation to conduct a sale process;

The consent solicitation process allows Medivation shareholders to demonstrate support for a transaction by removing and replacing the Medivation Board with directors committed to acting in the best interest of maximizing value for Medivation shareholders;

Sanofi believes there is a clear path to completion: the record date to determine Medivation shareholders entitled to give their written consent has been established as June 1, 2016; Sanofi expects the initial Hart-Scott-Rodino (HSR) waiting period to expire on June 13, 2016; Sanofi anticipates filing definitive consent solicitation materials in mid-June 2016; and Sanofi signed a consent on
June 3, 2016 for the shares it owns in Medivation and therefore expects that the 60-day consent solicitation period will conclude no later than August 1, 2016; and

Sanofi believes that Medivation’s shareholders overwhelmingly support the sale of Medivation and want Medivation to engage with Sanofi.