BUSINESS INSIGHTS, PHARMA TECH
Kindeva and | December 13, 2022
Kindeva Drug Delivery and Meridian Medical Technologies announced the completion of the transaction to combine the two companies. The combination has created a leading global contract development and manufacturing organization focused on drug-device combination products. The combination will operate under the Kindeva name, with Meridian operating as, “Meridian Medical Technologies, a Kindeva Company”.
The new Kindeva will have a broader range of drug delivery capabilities, with expertise and technology spanning the parenteral, inhalation, transdermal, and intradermal routes of administration. Milton Boyer, formerly the CEO of Meridian, has been named CEO of the newly combined company.
“The combination of Kindeva and Meridian creates a clear market leader in the drug-device CDMO sector. Customers will benefit from our enhanced scale and broader array of drug delivery solutions,”
Kindeva, formerly known as 3M Drug Delivery Systems, was acquired by Altaris, LLC in 2020 from 3M Company. Kindeva is a global leader in drug-device combination products with a focus on inhalation, transdermal, and intradermal drug delivery. The company has a long track record of innovation, having invented the first metered dose inhaler in the 1950s.
Meridian was acquired by Altaris in December 2021 from Pfizer Inc. Meridian is a leading manufacturer of emergency autoinjectors, having pioneered the emergency autoinjector technology in the 1950s. Meridian owns over 300 patents related to autoinjector drug-device combination products.
ArentFox Schiff LLP and Kirkland & Ellis LLP acted as legal counsel. JPMorgan Chase Bank, N.A., Truist Securities, Inc. and KeyBanc Capital Markets Inc. acted as joint lead arrangers for the transaction.
Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including autoinjectors, inhalers, transdermal patches, and microneedles. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K.
About Altaris, LLC
Altaris is a healthcare investment firm with an exclusive focus on building companies that deliver value to the healthcare system through innovation and efficiency. Since inception in 2003, Altaris has invested in 49 healthcare companies which have generated significant value appreciation for its investors. Altaris is headquartered in New York City and manages approximately $5 billion of equity capital.
BUSINESS INSIGHTS, PHARMA TECH
Innate Pharma | January 17, 2023
On January 16, 2023, Innate Pharma SA announced the publication of preclinical findings demonstrating the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123 in the scientific journal Nature Biotechnology. Innate and Sanofi conducted the experiments, which were published in Nature Biotechnology on January 12, 2023.
This study demonstrates that CD64 expression on AML blasts imparts resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and that redirecting NK cells against cancer targets by binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE primarily target NK cells and have substantial antitumor activity against primary AML blasts; they stimulate NK cell activation and cytokine secretion exclusively in AML cells' presence.
In vivo, its antitumor activity observed in a mouse tumor model surpasses that of the anti-CD123 antibody used as the comparator. Furthermore, in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates, the efficacy of CD123-NKCE was associated with the induction of low pro-inflammatory cytokine release and the absence of toxicity.
These results support CD123-NKCE clinical development. IPH6101/SAR'579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, is currently being evaluated in a Phase 1/2 clinical trial by Sanofi in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS).
About Innate Pharma
Headquartered in Marseille (France), Innate Pharma SA is a global, clinical-stage oncology-focused biotech firm dedicated to enhancing patient treatment and clinical outcomes using therapeutic antibodies that employ the immune system to combat cancer. Its extensive antibody pipeline has numerous potentially first-in-class clinical and preclinical candidates for cancers with a high unmet medical need. In addition, Innate has been a pioneer in the study of natural killer cell (NK cell) biology and developed its expertise in tumor antigens, tumor microenvironment, and antibody engineering. This innovative strategy has resulted in a varied proprietary portfolio and substantial alliances with biopharmaceutical industry leaders, including Sanofi, Bristol-Myers Squibb, Novo Nordisk A/S, and a multi-product collaboration with AstraZeneca.
BUSINESS INSIGHTS, PHARMACY MARKET
TherapeuticsMD, Inc. | December 05, 2022
TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into definitive agreements to license its products to an affiliate of Mayne Pharma Group Limited an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, for commercialization in the United States. In addition, TXMD has agreed to sell certain assets to Mayne Pharma to allow Mayne Pharma to commercialize the products.
At closing of the transaction, TXMD will receive an upfront cash payment of $140.0 million for the license grant and sale of certain assets, plus an additional approximately $13.1 million, subject to customary adjustments, for acquired net working capital. In addition, TXMD will receive a 20-year royalty stream tied to Mayne Pharma’s net sales of the products. The upfront payment to be made by Mayne Pharma, along with cash on hand, will allow TXMD to repay its outstanding indebtedness with Sixth Street Partners and to redeem its outstanding preferred equity, with TXMD continuing as a pharmaceutical royalty company with the potential to create value for stakeholders over time from the resulting net cash flows.
"After completing a thorough evaluation of several strategic alternatives, our Board of Directors concluded that this transaction with Mayne Pharma would create the most value for TherapeuticsMD’s stakeholders. This transaction will allow us to repay in full our debt to Sixth Street Partners and redeem our preferred stock from Rubric Capital Management, while also establishing a future royalty revenue stream for our common shareholders. We believe that Mayne Pharma has the experience necessary to fully realize the promise of our products as we work together to improve patient care.”
The Honorable Tommy Thompson, Executive Chairman of TherapeuticsMD
Upon completion of the transaction, which is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Act of 1976, Mayne Pharma will be responsible for development, regulatory filings, manufacturing, and commercialization of the Products.
TXMD will receive an upfront payment of $140.0 million for the sale of the assets and the grant of the licenses, plus a payment of approximately $13.1 million for the acquisition of net working capital, subject to certain customary adjustments.
In addition, Mayne Pharma will make one-time, milestone payments to the Company of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million. Further, Mayne Pharma will pay to the Company royalties on net sales of all licensed Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the closing. The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of the expiration or revocation of the last patent covering a Product and a generic version of a Product launching in the United States. Mayne Pharma will pay to the Company minimal annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments.
In connection with entering into the transaction, the lenders and administrative agent under the Company’s Financing Agreement with Sixth Street Partners have agreed to extend the maturity date of the Financing Agreement to December 31, 2022, allowing the Company to complete the transaction with Mayne Pharma on or before that date. The maturity date of the Financing Agreement may be further extended to January 31, 2023, upon payment of an amendment fee, in the event the definitive agreements in connection with the transaction remain in effect and the waiting period under the HSR Act has not expired or terminated.
The Company will retain its existing licensing agreements with Knight Therapeutics, Inc. and Theramex HQ UK Limited.
The transaction is not subject to any financing conditions and is expected to close at the end of 2022, pending satisfaction of customary closing conditions.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues.