BUSINESS INSIGHTS

Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings

Adare Pharma Solutions | December 02, 2021

Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings
Adare Pharma Solutions ("Adare"), a technology-driven contract development and manufacturing organization (CDMO), announced the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on oral formulations. The acquisition reinforces Adare's commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging.  Adare's portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services.  The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms.

 "We are devoted to improving the quality of life for patients by solving the most complex formulation challenges for our customers, and we believe this acquisition will bolster our ability to achieve our mission. Frontida and Adare share a commitment to quality and innovation, and we are excited to continue growing together.  The combined company will lead in the space of oral formulations, while expanding the services and technical offerings we provide to meet the needs of our customers and their patients."

Vivek Sharma, Chief Executive Officer of Adare 

Dr. Song Li, Frontida's Chairman added, "We are very excited about the opportunities this transaction is expected to provide to both existing and new clients. Our combined resources and capabilities will result in enhanced support and talent to ensure the success of their development and commercialization programs. This transaction is also a testament to the hard work, dedication, and caring culture of the team who has helped Frontida grow, enabling continued investment into the Philadelphia area, which is a respected home for pharmaceutical development and manufacturing. We look forward to continuing our work together to provide innovative, life-enhancing products to the US and global markets."

Together, the combined company will offer an expanded suite of solutions for complex oral formulations, such as taste masking, controlled release, high potency formulation manufacturing, and bioavailability enhancement. The addition of Frontida brings Adare's manufacturing footprint to seven sites globally and expands Adare's integrated, end-to-end offering to its partners. The combined organization will be led by Vivek Sharma.

Adare is backed by private equity firms Thomas H. Lee Partners and Frazier Healthcare Partners. RBC Capital Markets, LLC acted as exclusive financial advisor to Adare for this transaction.

About Adare
Adare Pharma Solutions is a leading specialty contract development and manufacturing organization (CDMO) and global provider of advanced pharmaceutical technologies, development services, and manufacturing. The Company utilizes its differentiated pharmaceutical technology and microbiome platforms to develop novel, improved medicines, and therapies for the global market.


Spotlight

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007 (see sidebar, Seven major trends reshaping the pharmaceutical marketplace).1 All these challenges have major ramifications for the way in which Pharma markets and sells the medicines it develops – the subject on which we shall focus here. The industry has traditionally relied on aggressive marketing to promote its products. One recent study estimates that, between 1996 and 2005, total real spending on pharmaceutical promotions rose from US$11.4 billion to US$29.9 billion in the US (the only country for which expenditure on all major marketing and sales activities is available).2 Another study suggests that the true figure (including meetings and e-promotions) is closer to US$57.5 billion in real terms.

Spotlight

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007 (see sidebar, Seven major trends reshaping the pharmaceutical marketplace).1 All these challenges have major ramifications for the way in which Pharma markets and sells the medicines it develops – the subject on which we shall focus here. The industry has traditionally relied on aggressive marketing to promote its products. One recent study estimates that, between 1996 and 2005, total real spending on pharmaceutical promotions rose from US$11.4 billion to US$29.9 billion in the US (the only country for which expenditure on all major marketing and sales activities is available).2 Another study suggests that the true figure (including meetings and e-promotions) is closer to US$57.5 billion in real terms.

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PHARMA TECH

Vivera Receives 3rd U.S. Patent Allowance for ZICOH Drug Delivery Device

Vivera Pharmaceuticals, Inc. | May 26, 2022

Vivera is pleased to announce the allowance of its third U.S. patent for ZICOH™, the Company's high-tech, electronic dose-controlled portfolio of drug delivery devices. The patent allowance from the U.S. Patent and Trademark Office secures ZICOH's rights as a smart dosing system with automated delivery, measurement, and management for oral format medications, including pills, capsules, and tablets. ZICOH is an electronic dose-controlled delivery device and technology designed to enable real-time communication through the drug supply chain, from drug manufacturers, distributors, and wholesalers to pharmacists, providers, physicians, caregivers, and patients. The device can be programmed to dispense the medication dosage type, amount, and frequency according to the health care provider's orders to ensure compliance with dispensed prescriptions while also implementing controls to help prevent medication misuse and abuse. Later versions of the device will also implement user authentication features, such as fingerprint authorization and facial recognition, to help prevent prescription drugs from being diverted. Medication reminders are another core feature of ZICOH. These reminders can be programmed into the device by the pharmacist per the physician's orders to alert the patient when it's time to take their medication. This feature can be particularly beneficial for patients who forget to take medications on time or for patients and caregivers who manage multiple medications. "ZICOH is a major innovation in the medical device and technology sectors. This device is going to make it easier than ever for patients to comply with their medication regimens, regardless of how complex they are." Mehdi Hatamian, Ph.D., Chief Scientific Advisor for Vivera This third patent differs from the device's two previously issued patents in that it specifically pertains to the dispensing of tablets, capsules, and pills. The device has already secured its patent rights as a secure, smart liquid and inhaler delivery device with automated dose delivery, measurement, and management. "We are proud of the progress we have made on the development of ZICOH's multiplatform uses and technology," said Paul Edalat, CEO and Chairman of Vivera. "The way that Tesla revolutionized the automotive industry, and the way Apple created a category for smart devices, is what Vivera is doing to the prescription dispensing industry. ZICOH will forever change the way that medications are prescribed and dispensed, and Vivera is reaching the milestones to get there in a fraction of the time projected." Vivera is looking forward to bringing ZICOH to market. The Company has already initiated the device's design and is looking forward to having a working prototype by late summer 2022. About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH™, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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PHARMACY MARKET

EyePoint Pharmaceuticals Announces Closing of $115.4 Million Public Offering

EyePoint Pharmaceuticals | November 20, 2021

EyePoint Pharmaceuticals, Inc. a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced the closing of the previously announced underwritten public offering of 5,122,273 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,095,000 shares of common stock, and pre-funded warrants to purchase up to an aggregate of 3,272,727 shares of its common stock. The shares of common stock were sold at a public offering price of $13.75 per share, and the pre-funded warrants were sold at a purchase price of $13.74 per pre-funded warrant, for aggregate gross proceeds of approximately $115.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by EyePoint. All of the securities were sold by EyePoint. Cowen and Guggenheim Securities acted as joint book-running managers for the offering. Cantor acted as passive book-running manager for the offering. EyePoint intends to use the net proceeds from the offering to advance EYP-1901 into and through Phase 2 clinical trials for wet AMD, DR, and RVO, as well as support its earlier stage pipeline development initiatives, and for general corporate purposes. The securities described above were offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-258598) previously filed with the Securities and Exchange Commission (SEC) on August 6, 2021 and declared effective by the SEC on August 11, 2021. The securities were offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 18, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes stock price volatility and uncertainties relating to the financial markets, the continued impact of the COVID-19 pandemic on EyePoint’s business, the medical community and the global economy, and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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PHARMACY MARKET

Atara Biotherapeutics and Pierre Fabre Enter Strategic Collaboration to Commercialize Tabelecleucel (Tab-cel®)

Atara Biotherapeutics, Inc. | October 04, 2021

Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre today announced an exclusive commercialization agreement for tabelecleucel (tab-cel®) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers. Atara will retain full rights to tab-cel® in other major markets, including North America, Asia Pacific, and Latin America. Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel® in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel® to be paid by Pierre Fabre. Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel® is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel® has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA). Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships, Our Companies’ complementary capabilities will expand access to tab-cel®, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers. - Pascal Touchon, President and CEO of Atara. Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology. PJT Partners served as the exclusive financial advisor to Atara. About Tabelecleucel Tabelecleucel (tab-cel®) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences. Tab-cel® is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care. Tab-cel® has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel® has orphan drug designation in the U.S. and EU. About Pierre Fabre Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio ranges across several medical franchises and international brands, including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive and Pierre Fabre Oral Care. In 2020, Pierre Fabre generated €2.3 billion in revenues, 65% of which came from international sales. Established in the South-West area of France since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan. In 2020, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard for the 2nd consecutive year and confirmed its “Excellence” level. For further information, please visit the Pierre Fabre website at www.pierre-fabre.com. About Atara Biotherapeutics, Inc. Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California.

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