Novo Nordisk has agreed to acquire Inversago Pharma for up to $1.075 billion in cash if certain development and commercial milestones are achieved. Inversago Pharma is a private, Montreal-based developer of CB1 receptor-based therapies for the potential treatment of obesity, diabetes and complications associated with metabolic disorders.

The acquisition of Inversago includes the company’s lead development asset INV-202, an oral CB1 inverse agonist. INV-202 is designed to preferentially block the receptor protein CB1 – which plays an important role in metabolism and appetite regulation – in peripheral tissues such as adipose tissues, the gastro-intestinal tract, the kidneys, liver, pancreas, muscles and lungs.

INV-202 demonstrated weight loss potential in a phase 1b trial and is currently in a phase 2 trial for diabetic kidney disease (DKD). Additional pipeline assets are also being developed for metabolic and fibrotic disorders. Novo Nordisk intends to investigate the potential of INV-202 for obesity and obesity-related complications.

CB1 plays an important role in appetite regulation and other cardiometabolic pathways. The mechanistic and preclinical therapeutic effects of peripheral CB1 receptor blocking are well-studied across a range of cardiometabolic and fibrotic diseases, supporting the potential treatment of many people with current unmet needs.

Inversago employs 22 people, who will continue to focus on the successful completion of the ongoing and planned trials, while working closely with Novo Nordisk to drive Inversago’s technology forward in future clinical trials. The closing of the acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to happen before the end of 2023.

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Sigachi Industries has forayed into the active pharmaceutical ingredient (API) business by acquiring a majority stake (80 per cent) in an API manufacturing company, Trimax Bio Sciences, located in Raichur, Karnataka.

A company statement informed that the API unit, located in Raichur, Karnataka, 180 km from Hyderabad, is equipped with cutting-edge technology and is in compliance with the stringent international quality standards of USFDA, EMEA and WHO. Additionally, the API unit is approved by USFDA for advanced and critical intermediates. It added that the acquired API unit will synergise seamlessly with Sigachi’s existing portfolio of excipients and will provide one stop solution for customers’ API and non-API needs.

Commenting on this strategic development, Amit Raj Sinha the MD & CEO of Sigachi Industries, stated, “We are thrilled to venture into the API business, which presents vast opportunities to further strengthen our presence in the pharmaceutical industry. The acquisition of this well-equipped API unit aligns perfectly with our mission to deliver superior healthcare solutions globally. This expansion is a testament to our commitment to innovation and customer satisfaction.”

With this acquisition, Sigachi is set to enhance its capabilities in developing and supplying a diverse range of APIs, catering to a wide spectrum of therapeutic areas, including cardiovascular, anti-diabetic, anti-infective, anti-viral, and central nervous system medications, among others with molecules like Pregabalin, Ritonavir, Metformin Hcl, Propafenone Hcl, Atorvastatin Ca Trihydrate, Nimorazole, Naftopidil, Meclizine Hcl and their intermediates.

Sigachi’s foray into API business opens up new doors for further collaboration with its customers operating in over 60 countries.

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Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications

Novartis has announced that it has acquired DTx Pharma, a San-Diego based, preclinical stage biotechnology company focused on leveraging its proprietary FALCON platform to develop siRNA therapies for neuroscience indications.

DTx’s lead program, DTx-1252 targets the root cause of CMT1A—the overexpression of PMP22, a protein that causes the myelin sheath that supports and insulates nerves in the peripheral nervous system to function abnormally. DTx-1252, which was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), decreases the expression of this protein in Schwann cells, the target cell type for the development, maintenance, and function of peripheral nerves. The FALCON platform facilitates this targeted approach by conjugating siRNAs to naturally occurring fatty acids to improve the biodistribution and cellular uptake to tissues and cell types of interest.

Fiona Marshall, President of the Novartis Institutes for BioMedical Research (NIBR) said, “We look forward to continuing the development of DTx’s therapeutic programs and bringing new hope to patients with neuromuscular and other neurological disorders for which there have historically been few treatment options. We are also excited to bring DTx’s FALCON technology to Novartis and explore its potential to deliver drugs to extrahepatic tissues.”

In addition to DTx-1252, the deal also brings two additional preclinical programs for other neuroscience indications to Novartis and expands the Novartis siRNA toolkit, building on its capabilities in xRNA, one of the Novartis technology platforms.

Robert Baloh, Global Head of Neuroscience for NIBR said, “The growing arsenal of therapeutic platforms available to us continues to enable the development of novel, high-value medicines—particularly in cases where the underlying biology of disease is well defined. We look forward to continuing the development of DTx’s potential first-in-class medicine for CMT1A and are hopeful we can bring a therapeutic option to patients living with this debilitating neuromuscular condition.”

Under the terms of the agreement, Novartis will make an upfront payment of USD 500m and additional payments upon completion of pre-specified milestones.

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Announce exclusive US distribution pact, distribution expected to start during the second half of 2023

Glenmark Pharmaceuticals and Cediprof (a part of the Neolpharma Pharmaceutical Group family of companies) have entered into an exclusive supply and distribution agreement for Cediprof’s FDA-approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, the generic version of Adderall®1 Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women’s Health, Inc.

Glenmark expects to commence distribution of the product, in the US, which has been on FDA’s shortage list for quite some time, during the second half of 2023.

According to IQVIA’s National Sales Perspectives: Retail & Non-Retail, January 2023, sales data for the 12-month period ending January 2023 showed that the Adderall® Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market achieved annual sales of approximately $389.8 million.

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Redx Pharma and Jounce Therapeutics announce an unanimously recommended Business Combination of the two companies via a proposed all share merger transaction. Redx is a clinical-stage biotechnology company focused on the discovery and development of novel, small molecule, targeted therapeutics for the treatment of cancer and fibrotic diseases and the emerging area of cancer-associated fibrosis. Jounce is a clinical-stage immunotherapy company developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker approach. The Business Combination will create a transatlantic organisation with proven expertise in both small molecule drugs and biologics, and a clinical pipeline with multiple value inflection points in the near and medium term.

The combined group’s highest priority will be the development of RXC007, a next-generation selective ROCK2 inhibitor, which is currently being assessed in a Phase 2a study in idiopathic pulmonary fibrosis (IPF), with topline data expected in Q1 2024. ROCK2 inhibition is now a commercially validated target with potential in multiple disease areas, following the recent US FDA approval and launch of the first drug with this mechanism of action. In addition to the ongoing clinical development plan in IPF, Redx has also generated supportive preclinical data that highlights the broad potential of next-generation ROCK2 inhibitors across a number of fibrotic indications where there remains a significant unmet need, which supports potential development opportunities in other interstitial lung diseases and cancer-associated fibrosis. Additionally, RXC004 is being developed as a targeted treatment for Wnt-ligand dependent cancers and is progressing through Phase 2 trials, and RXC008, a GI-targeted ROCK inhibitor for fibrostenotic Crohn’s disease, is expected to enter clinical development in H1 2024.

At the time of the completion of the Business Combination, Jounce is expected to have around $155 million of cash and cash equivalents, which net of any tail and closing costs results in at least $130 million in cash and cash equivalents available to the combined group. Together with Redx’s expected cash at completion would provide the combined group with cash runway into H2 2025. Based on Redx’s fully diluted market capitalisation of £244 million ($294 million) as at the Last Practicable Date and Jounce’s expected cash and cash equivalents at the time of completion, this implies a market value for the combined group of $425 million, before taking into account the value of Jounce’s existing clinical and non-clinical stage programs.

This announcement follows the earlier news that Jounce plans to reduce its workforce by approximately 57 per cent. After completion of the transaction, around 47 Jounce employees will be retained by the combined group at a research and development base in Massachusetts, US and will bring complementary expertise in biologics and immuno-oncology. Jounce’s clinical programs will not be pursued in-house beyond the currently ongoing studies.

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Control Print announced a joint venture with V-Shapes S.r.l., a supplier of sustainable single-dose sachets and manufacturer of packaging machinery based in Bologna, Italy. A company statement informed that through this joint venture, Control Print and V-Shapes will collaborate to produce recyclable/biodegradable single-use packets for a wide range of products including liquids, viscous and powdered content.

V-Shapes has developed unit-dose packaging machines in collaboration with Siemens, designed to create a system with “Snap then Squeeze” technology that requires only three fingers to open a sachet without cutting and tearing. This packaging machine developed by V-Shapes is intended to reduce the environmental impact of packaging. The single-portion pouches are easy to open, hygienic and safe to use, making them ideal for food, cosmetics, medicines, pharma and chemical products.

This partnership will allow Control Print to expand its reach in the Indian market and provide customers with a broader range of recyclable packaging, technologically advanced packaging machinery and a complete range of coding solutions.

V-Shapes has also created two new substrates, reNEW oX-100 and reNEW oX-500, equipped with high-barrier capabilities and certified by Interseroh as 100 per cent recyclable.

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Sun Pharma today acquired three brands viz Disperzyme (Trypsin BP 96 mg, Bromelain 180 mg and Rutoside Trihydrate 200 mg), Disperzyme-CD (Trypsin BP 48 mg, Bromelain 90 mg and Rutoside Trihydrate 100 mg) and Phlogam (Trypsin BP 48 mg, Bromelain 90 mg and Rutoside Trihydrate 100 mg) from Aksigen Hospital Care, a Mumbai-based research-driven healthcare entity with over two decades of experience in the healthcare field. All the brands are approved by the Drugs Controller General of India (DCGI) for post-operative inflammation in patients undergoing minor surgery and dental procedures, according to a company statement.

All the brands are approved by the Drugs Controller General of India (DCGI) for post-operative inflammation in patients undergoing minor surgery and dental procedures, said the statement.

Disperzyme and Phlogam are the first enzyme-bioflavonoid combination of Trypsin, Bromelain and Rutoside (TBR) to complete a clinical study in India and get DCGI approval. The brands were registered and launched in India by Aksigen in 2013, added the statement.

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Prochem’s Pharma Division has merged with Tapasya, a proven expert in granulation and a single-stop solution provider of solid formulations to pharma, nutra and food industries. This will help the companies leverage their combined expertise, manufacturing strengths and market knowledge, and further strengthen Prochem’s efforts in its quest to offer innovative and customised solutions to enterprises across verticals from Active Pharma Ingredients (APIs) to formulations in various geographies and many industries like speciality chemicals, agro chemicals, nutraceuticals, etc.

The new business entity, Prochem Tapasya, will add value to create a one-stop solution for pharma and allied industries. The value proposition for customers will be in terms of project execution at a faster pace, and, hence, better Return on Investment (RoI). The alliance will also add value in terms of quality and cost optimisation.

“…..As a leader in granulation, Tapasya has its own distinct strengths in the pharma and FMCG industries, and its RMG specially the Sizoner is the highest sold machine in the global market and widely used across industries. Together, we will be able to offer our clients across verticals, innovative solutions that deliver better performance and reliability going forward. We can grow to become stronger and have a better impact, a reflection of the ‘Make in India’ vision we have been pursuing,” said Shashi Rai, Director, Prochem.

Together, the new business entity Prochem Tapasya is poised to revolutionise the pharma industry from API to formulations through innovative product offerings. The merger to form a new entity Prochem Tapasya, comes at a time when the Indian pharma industry is growing at a rapid clip. The domestic Pharma market is projected to touch $65 billion by 2024 and $120-130 billion by 2030, offering tremendous growth potential for this joint venture.

“I envision Prochem’s merger with Tapasya’s as one with a far-reaching impact. We now have the expertise and bandwidth to address businesses across verticals with solutions in powder handling and granulation. With India consolidating its leadership in pharma and several other domestic markets growing rapidly, the demand for innovative solutions is only going to increase. Together, we will be best placed to leverage this opportunity,” said Nitesh Srivastav, Business Head, Prochem.

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Sun Pharma will acquire all outstanding shares of Concert through a tender offer for an upfront payment of $8.00 per share of common stock in cash, or $576 million in equity value. Concert stockholders will also receive a non-tradeable Contingent Value Right (CVR) entitling holders to receive up to an additional $3.50 per share of common stock in cash, payable upon deuruxolitinib achieving certain net sales milestones within specified periods, subject to the terms and conditions contained in a contingent value rights agreement detailing the terms of the CVRs, a statement from Sun Pharma notified yesterday.

Under the terms of the merger agreement, Sun Pharma will commence a tender offer to acquire all outstanding shares of Concert common stock. Concert stockholders will be offered an upfront payment of $8.00 per share of common stock in cash. Concert’s Board of Directors unanimously recommends that Concert stockholders tender their shares in the tender offer, the statement said.

Further, according to the statement, Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. It has an extensive patent portfolio, including its lead product candidate deuruxolitinib – an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an auto-immune dermatological disease – which is in late-stage development. Concert has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate-to-severe Alopecia Areata in its Thrive-AA phase-III clinical programme and two open-label, long-term extension studies are ongoing in North America and Europe. Sun Pharma’s immediate focus would be to follow Concert’s plan to submit a New Drug Application (NDA) to the United States Food and Drug Administration (USFDA) in the first half of 2023.

“Sun Pharma is building a global dermatology and ophthalmology franchise and aims to be a preferred development and commercial partner in these therapies worldwide. The acquisition of Concert adds a late-stage, potential best-in-class treatment for Alopecia Areata in deuruxolitinib,” said Abhay Gandhi, CEO, North America, Sun Pharma, in the statement.

Concert stockholders will also receive a non-tradeable CVR, which entitles Concert stockholders to receive up to an additional $3.50 per share of common stock in cash, payable upon deuruxolitinib achieving certain net sales milestones within specified periods, subject to the terms and conditions contained in the contingent value rights agreement detailing the terms of the CVRs. These milestones, subject to terms and conditions as specified in the contingent value rights agreement, include: (i) $1.00 per share of common stock, payable the first time that in any fiscal year between the time of the first commercial sale of deuruxolitinib in the US and 31st March, 2027, net sales of deuruxolitinib is equal to or exceeds $100 million, and (ii) an additional $2.50 per share of common stock, payable the first time that in any period of four consecutive fiscal quarters between the time of the first commercial sale of deuruxolitinib in the US and 31st December, 2029, net sales of deuruxolitinib is equal to or exceeds $500 million. There can be no assurance that any payments will be made with respect to the CVRs, the statement added.

The transaction is expected to be completed in the first quarter of 2023. It is subject to the tender of a majority of the outstanding shares of Concert’s common stock, as well as the receipt of applicable regulatory approvals and other customary closing conditions. Following the closing of the tender offer, Sun Pharma will acquire all remaining shares of Concert that are not tendered into the tender offer and all shares of Concert’s preferred stock through a second-step merger at the same price of $8.00 per share of common stock, plus one non-tradeable CVR. The merger will be effected as soon as practicable after the closing of the tender offer, concluded the statement.

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Quantumzyme today collaborated with BEC Chemicals to develop sustainable biotransformation and biocatalysis solution for the pharma industry, the companies said in a joint statement.

According to the statement, the agreement grants both parties access to each other’s knowledge and expertise to develop novel solutions for Active Pharmaceutical Ingredient (API) development. Quantumzyme’s expertise in rapid enzyme discovery, enzyme engineering and pilot validation into early-phase projects complements BEC Chemicals’ experience and track record of over 30 commercial manufacturing chemical reactions run on a multi-ton scale. This will give either party customers access enzyme expertise and assets, resulting in cost-effective, green processing for API manufacturing.

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