On October 18, 2022 Eli Lilly and Company (NYSE: LLY) and Akouos, Inc. (NASDAQ: AKUS) reported a definitive agreement for Lilly to acquire Akouos, a precision genetic medicine company that is developing a portfolio of first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss (Press release, Eli Lilly, OCT 18, 2022, View Source [SID1234622098]).

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"We are honored to work with the talented team at Akouos who are breaking new ground in the science of treating hearing loss," said Andrew C. Adams, Ph.D., senior vice president of genetic medicine and co-director of the Institute for Genetic Medicine, Lilly. "We believe that with Lilly’s resources, global reach, and growing capabilities in gene therapy, we can help Akouos fulfill their mission of making healthy hearing available to all."

Akouos has integrated expertise across otology, inner ear drug delivery, and gene therapy with the goal of addressing the needs of people living with disabling hearing loss worldwide. Akouos’s lead product candidate, AK-OTOF, is a gene therapy for the treatment of hearing loss due to mutations in the otoferlin gene (OTOF). Additional pipeline programs span across multiple inner ear conditions, and include AK-CLRN1 for Usher Type 3A, an autosomal recessive disorder characterized by progressive loss of both hearing and vision; GJB2 (which encodes connexin 26) for a common form of monogenic deafness and hearing loss; and AK-antiVEGF for the treatment of vestibular schwannoma.

"I am proud of the commitment and passion of our team, which has established Akouos as a pioneer in inner ear genetic medicine, as demonstrated by our work to advance the first investigational therapy for a genetic form of hearing loss into clinical development," said Emmanuel Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. "Joining Lilly – a company that shares our purpose to make life better for people around the world – will help us accelerate the development of a broad pipeline of inner ear genetic medicines."

Under the terms of the transaction, Lilly will acquire all of the outstanding shares of Akouos for $12.50 per share in cash, plus one contingent value right (CVR) of up to $3.00 per share. The deal has been approved by the boards of directors of both companies.

"Gene therapy offers tremendous opportunity to provide durable treatments for patients with genetically defined disease; this is our second acquisition in gene therapy, following the 2021 acquisition of Prevail Therapeutics," added Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. "With Akouos, we are optimistic that we can make a difference for people with hearing loss and other inner ear conditions."

Terms of the Agreement

Lilly will commence a tender offer to acquire all outstanding shares of Akouos for a purchase price of $12.50 per share in cash (an aggregate of approximately $487 million) payable at closing plus one non-tradeable contingent value right per share ("CVR") that entitles the holder to receive up to an additional $3.00 in cash, for a total consideration of up to $15.50 per share in cash without interest (an aggregate of up to approximately $610 million).

CVR holders would become entitled to receive contingent payments as follows: (i) $1.00 in cash, upon the fifth (5th) participant being administered with AK-OTOF in a Phase 1 or Phase 1/2 trial on or prior to Dec. 31, 2024; (ii) $1.00 in cash, upon the fifth (5th) participant being administered with an Akouos gene therapy product for a second monogenic form of sensorineural hearing loss (excluding AK-OTOF and AK-antiVEGF) on or prior to Dec. 31, 2026; and (iii) $1.00 in cash, upon (a) the first (1st) participant being administered with an Akouos gene therapy product (excluding AK-antiVEGF) for a monogenic form of sensorineural hearing loss in a Phase 3 trial, or (b) receipt of FDA approval in the U.S. for such Akouos product, whichever occurs first, on or prior to Dec. 31, 2026, or its value will be reduced by approximately 4.2 cents per month until Dec. 1, 2028 (at which point the CVR will expire).

There can be no assurance that any payments will be made with respect to the CVR. The transaction is not subject to any financing condition and is expected to close in the fourth quarter of 2022, subject to customary closing conditions, including receipt of required antitrust clearance and the tender of a majority of the outstanding shares of Akouos’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Akouos that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

The purchase price payable at closing represents a premium of approximately 121% to the 30-day volume-weighted average trading price of Akouos’s common stock ended on Oct. 17, 2022, the last trading day before the announcement of the transaction. Akouos’s Board of Directors unanimously recommends that Akouos’s stockholders tender their shares in the tender offer. Additionally, certain Akouos stockholders, beneficially owning approximately 26% of Akouos’s outstanding common stock, have (subject to certain terms and conditions) agreed to tender their shares in the tender offer.

Lilly will determine the accounting treatment of this transaction as a business combination or an asset acquisition, including any related acquired in-process research and development charges, according to Generally Accepted Accounting Principles (GAAP) upon closing, which is expected to occur in the fourth quarter of 2022. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For Akouos, Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal counsel and Centerview Partners LLC as sole financial advisor.

On October 18, 2022 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its third quarter sales 2022 (January 1 – September 30, 2022) (Press release, Chugai, OCT 18, 2022, View Source [SID1234622096]).

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Roche owns 59.89% of Chugai’s outstanding shares (61.14% of voting rights) as of the end of June 2022.

Its investor update and presentation materials can be found on its website (View Source).
Chugai’s performance for the period of January 1 to September 30, 2022 is included in the announced Roche Group’s results.

On October 18, 2022 LG Chem, Ltd. ("LG Chem") (KOSPI: 051910) and AVEO Oncology ("AVEO") (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, reported that they have entered into a definitive agreement under which LG Chem will acquire AVEO for $15.00 per share in an all-cash transaction with an implied equity value of $566 million on a fully diluted basis (Press release, AVEO, OCT 18, 2022, View Source [SID1234622095]).

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The combination of LG Chem’s Life Sciences division and AVEO is expected to create a global oncology organization with a robust portfolio of innovative products supported by full capabilities from discovery to clinical, biologics manufacturing and U.S. commercialization, at a scale capable of broadly delivering on its mission to improve the lives of patients with cancer. Bringing together AVEO and LG Chem is expected to extend LG Chem Life Sciences’ commercial footprint to the U.S., diversify its pipeline with a broad range of oncology therapies and accelerate LG Chem’s efforts to deliver continued growth through the development and commercialization of world-class cancer therapies.

Through this transaction, AVEO will immediately establish LG Chem’s commercial presence in oncology through AVEO’s lead product, FOTIVDA (tivozanib), which received U.S. Food and Drug Administration (FDA) approval in March 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. In addition, the combined company will have significantly greater resources to develop and commercialize both companies’ robust clinical pipelines of innovative oncology medicines.

Upon completion of the transaction, AVEO will establish and operate as the U.S. commercial foundation for LG Chem Life Sciences’ oncology segment. Through this transaction, the combined company will expand its high-value and sustainable pipelines in oncology and bring cancer therapies to patients in need.

"With its track record of clinical success, deep pipeline of innovative therapies and continued growth trajectory following the successful commercialization of FOTIVDA, AVEO is the perfect partner for LG Chem Life Sciences," said Shin Hak-Cheol, Chief Executive Officer of LG Chem. "This transaction represents the next step in our portfolio transformation towards higher growth markets and provides a strong commercial foundation in oncology as we continue to develop our anti-cancer offerings. We remain focused on prudently investing in our R&D capabilities, continuing to build a leading portfolio of therapies and transforming lives through inspiring science and leading innovation. With our shared values of collaboration, agility and passion, we are excited to welcome AVEO and its talented employees to LG Chem as we continue to advance our sustainable goal of becoming one of the top global pharmaceutical companies."

"We are thrilled to announce this transaction, which delivers a compelling all-cash premium to our shareholders, while positioning AVEO to accelerate our strong momentum to the benefit of the oncology patients we serve," said Michael Bailey, President and Chief Executive Officer of AVEO. "By joining forces with LG Chem, AVEO expects to have significant financial and development resources to help AVEO fully realize the tremendous potential of our promising pipeline. LG Chem shares AVEO’s deep commitment to patients and vision of developing innovative therapies designed to provide substantial impact in the lives of cancer patients with clear unmet medical needs. This transaction is a testament to the extraordinary efforts of our employees, who will play an integral role in the success of the combined company. We look forward to entering our next chapter of growth with the support of LG Chem."

"This transaction represents the culmination of a thorough review of opportunities by the Board to maximize shareholder value and delivers compelling value to AVEO shareholders," said Kenneth Bate, AVEO’s Chairman of the Board. "We are confident that with the support and resources of LG Chem, AVEO will continue advancing its mission of passionately pursuing a better life for patients with cancer."

LG Chem is actively advancing multiple clinical and pre-clinical stage anti-cancer therapies. LG Chem will be able to harness the full potential in oncology through this transaction and become a global, fully integrated – from R&D to commercial stage – pharmaceutical company.

Transaction Terms and Closing

The transaction price represents a 43% premium to AVEO’s closing share price on October 17, 2022, as well as a 71% premium to its 30 trading day volume-weighted average price. The transaction, which was unanimously approved by both companies’ Boards of Directors, is expected to close in early 2023, subject to customary closing conditions, including approval by AVEO shareholders and receipt of regulatory approvals. The transaction is not subject to any financing condition. LG Chem expects to finance the transaction with existing and available cash resources. Upon completion of the transaction, AVEO’s shares will no longer trade on the Nasdaq.

The combined company will be headquartered in Seoul, South Korea, and LG Chem also expects to maintain a significant presence in Boston and Cambridge, Massachusetts, the location of the LG Chem Life Sciences Innovation Center.

AVEO Third Quarter 2022 Financial Results

AVEO expects to report third quarter 2022 financial results on Monday, November 7, 2022. Given the transaction announced today, AVEO will not conduct an earnings conference call or provide financial guidance in conjunction with its third quarter 2022 earnings release.

Advisors

BofA Securities is serving as exclusive financial advisor to LG Chem, and Latham & Watkins LLP is serving as LG Chem’s legal counsel. Moelis & Company LLC is serving as exclusive financial advisor to AVEO, and WilmerHale LLP is serving as AVEO’s legal counsel.

On October 18, 2022 Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that it has signed a licensing agreement with Cristal Therapeutics to gain access to its CliCr metal-free click chemistry (Press release, Synaffix, OCT 18, 2022, View Source [SID1234622093]).

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Under the terms of the agreement, Synaffix will obtain exclusive rights to the CliCr technology, to combine with its proprietary ADC platform technology. This further expands the GlycoConnect ADC tool kit by significantly enhancing the versatility across cytotoxic payloads and supports further expansion into antibody-based targeted gene therapy and immune cell engager applications.

On October 18, 2022 GSK plc (LSE/NYSE: GSK) and Tempus, a US-based precision medicine company, reported that have entered into a three-year collaboration agreement that provides GSK with access to Tempus’ AI-enabled platform, including its library of de-identified patient data (Press release, GlaxoSmithKline, OCT 18, 2022, View Source [SID1234622092]). Through its leading Artificial Intelligence and Machine Learning (AI/ML) capability, GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets. This will contribute to GSK’s R&D success rate and provide patients with more personalised treatment faster.

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The new collaboration builds from the existing relationship between the companies that began in 2020 on clinical trial enrolment of patients with certain types of cancer. It will now expand GSK’s access to de-identified patient data bringing greater scale and detail. Tempus’ dataset draws from its work with over 40% of oncologists in the U.S. at academic medical centres and community hospitals.

Tony Wood, Chief Scientific Officer, GSK, said: "This collaboration will provide GSK with unique insights to discover better medicines and transform drug discovery. Tempus complements the work our team is already doing at the intersection of genomics and machine learning across both early discovery and clinical trials."

GSK’s investments in human genetics, functional genomics and AI/ML have enabled the company to more than double the number of targets in the early portfolio since 2017 and have increased the proportion of those with genetic support beyond 70%. Medicines with genetic validation are twice as likely to become registered medicines. As a leader in AI-enabled precision medicine, Tempus has developed a platform that provides a rapid way of testing complex biomarker hypotheses. Powered by machine learning, this is an important component of selecting patients who could benefit from candidate medicines in GSK’s portfolio in the future.

Eric Lefkofsky, Founder and CEO, Tempus, said: "GSK’s data-first approach to therapeutic research aligns with our own, and we believe that Tempus has the resources and capabilities to complement GSK’s dedication to data science, in a way others can’t given the breadth and depth of our platform. We both share a commitment to providing patients with more personalised therapeutic options to help them live longer and healthier lives."

GSK and Tempus currently collaborate on an open label phase II study, which applies an innovative, data-driven approach designed to accelerate and streamline study timelines. This includes expediting the protocol development and intelligent site selection in under 60 days and enrolling its initial patients within three months of the study launch.

The expanded collaboration has a minimum financial commitment over three years, for which GSK made a $70 million initial payment. GSK then has an option to extend for two additional years.