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CDMO Services for Pharmaceuticals 2024

CDMO Services for ADCs 2024

Finorga GMP Certificate 2024

Farmabios GMP Certificate 2024

PharmaZell GMP Certificate 2023

Novasep GMP Certificate 2022

Seripharm GMP Certificate 2021

Martin Meeson Appointed as CEO of Axplora

PharmaZell & Novasep Announce the Closing of their Merger.

In Negotiations with Novasep for Complex Small Molecules & ADCs

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CPHI Barcelona 2023: CCO Arul Ramadurai

CDMO Leadership Awards 2023-Arul Ramadurai Interview

Three Legacies, One Company 2022

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025.

Impressions: 1204

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.

Impressions: 3165

NEWS #PharmaBuzz

Martin Meeson appointed as CEO of Axplora

10 Apr 2024

// PRESS RELEASE

Axplora plans €8m investment at French facility

30 Jan 2024

// PRESS RELEASE

Axplora announces the appointment of its Scientific Advisory Board

13 Nov 2023

// PRESS RELEASE

Axplora announces the appointment of its Scientific Advisory Board

13 Nov 2023

// PRESS RELEASE

Axplora's Ursodeoxycholic Receives 5-Year Renewed Registration

07 Nov 2023

// PRESS RELEASE

Axplora appoints Dr. Stephan Haitz as President of its Novasep CDMO Business Unit

18 Oct 2023

// PRESS RELEASE

ALL APIs

01

Mesalazine

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

Click Us!

CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF EU, CA, ...

AUDIT

02

Acetylcysteine

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF VMF EU, CA, ...

AUDIT

03

Betamethasone Valerate

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF VMF Others AUDIT

04

Celecoxib

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC

NDC KDMF

VMF EU, CA

AUDIT

05

Clobetasol Propionate

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF SAU

AUDIT

06

Medroxyprogesterone Acetate

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

07

Methylene Blue

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF EU

AUDIT

08

Propafenone Hydrochloride

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF EU, CA, ...

AUDIT

09

Teriflunomide

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF EU-WC

NDC KDMF VMF Others AUDIT

10

Triamcinolone Acetonide

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

Only 10 entries up to this point, click to access all

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USDMF

01

5-aminosalicylic Acid (mesalazine/me...

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-16

Pay. Date : 2014-11-28

DMF Number : 8070

Submission : 1989-05-09

Status : Active

Type : II

02

Balsalazide Disodium

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2021-08-10

Pay. Date : 2021-08-06

DMF Number : 16425

Submission : 2003-02-17

Status : Active

Type : II

03

Beclometasone Dipropionate Monohydra...

Germany

Axplora

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21972

Submission : 2008-09-11

Status : Active

Type : II

04

Beclomethasone Dipropionate

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2019-04-25

Pay. Date : 2019-04-22

DMF Number : 12813

Submission : 1998-01-05

Status : Active

Type : II

05

Betamethasone Dipropionate Micronize...

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-07

Pay. Date : 2013-09-26

DMF Number : 23118

Submission : 2009-09-16

Status : Active

Type : II

06

Betamethasone Valerate

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2018-08-14

Pay. Date : 2018-07-09

DMF Number : 12749

Submission : 1997-11-18

Status : Active

Type : II

07

Budesonide

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-16

Pay. Date : 2013-05-03

DMF Number : 18910

Submission : 2005-10-26

Status : Active

Type : II

08

Budesonide Micronized Sterile

Germany

Axplora

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25615

Submission : 2011-12-20

Status : Active

Type : II

09

Busulfan

Germany

Axplora

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-08

Pay. Date : 2012-12-17

DMF Number : 25933

Submission : 2012-03-27

Status : Active

Type : II

10

Cannabidiol

Germany

Axplora

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34029

Submission : 2019-07-24

Status : Active

Type : II

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CEP/COS

01

Acetylcysteine

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R2-CEP 1995-028 - Rev 04

Status : Valid

Issue Date : 2020-12-15

Type : Chemical

Substance Number : 967

02

Beclometasone dipropionate, Micronised, ...

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R1-CEP 2001-315 - Rev 02

Status : Valid

Issue Date : 2017-06-28

Type : Chemical

Substance Number : 654

03

Betamethasone dipropionate, Micronised

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R1-CEP 2003-232 - Rev 03

Status : Valid

Issue Date : 2023-02-08

Type : Chemical

Substance Number : 809

04

Betamethasone valerate, Micronised

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R1-CEP 2002-078 - Rev 03

Status : Valid

Issue Date : 2021-03-22

Type : Chemical

Substance Number : 811

05

Budesonide, micronised

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R1-CEP 2000-051 - Rev 02

Status : Valid

Issue Date : 2010-05-04

Type : Chemical

Substance Number : 1075

06

Budesonide, Micronised, grades 21, 22 an...

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R1-CEP 2005-174 - Rev 01

Status : Valid

Issue Date : 2017-07-25

Type : Chemical

Substance Number : 1075

07

Busulfan

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R0-CEP 2018-265 - Rev 00

Status : Valid

Issue Date : 2020-03-24

Type : Chemical

Substance Number : 542

08

Carbocisteine

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : R1-CEP 1998-038 - Rev 05

Status : Valid

Issue Date : 2017-05-19

Type : Chemical

Substance Number : 885

09

Celecoxib

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : CEP 2012-151 - Rev 02

Status : Valid

Issue Date : 2023-11-09

Type : Chemical

Substance Number : 2591

10

Chlormadinone acetate, Micronised (grade...

Germany

PharmaVenue

Not Confirmed

Axplora

Certificate Numbers : CEP 2018-122 - Rev 03

Germany

PharmaVenue

Axplora

Date of Issue : 2022-03-18

Valid Till : 2025-05-28

Written Confirmation Number : WC-0019

Address of the Firm : Plot No. 115, Ramky Pharma Cit...

Only 10 entries up to this point, click to access all

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KDMF

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NDC API

Only 10 entries up to this point, click to access all

LISTED APIs

01

16Alpha-Hydroxyprednisolone

Germany

Germany

Duphat

Not Confirmed

Axplora

Stock Recap
#Pipeline Prospector

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Drugs in Development

01 Axplora

Germany

Cosmoprof

Not Confirmed

Lead Product(s) : Omadacycline

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Paratek Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Collaboration

Novasep And Paratek Enhance Collaboration to Manufacture Omadacycline (NUZYRA®), A Novel Tetracyc...

Details : Under the terms of the collaboration, Novasep and Paratek will manufacture NUZYRA® (omadacycline), an FDA-approved tetracycline-class, once-daily oral and intravenous antibiotic for the treatment of adults with CABP and acute bacterial skin and skin str...

Brand Name : Nuzyra

Molecule Type : Small molecule

Upfront Cash : Undisclosed

February 15, 2022

02 Axplora

Germany

Cosmoprof

Not Confirmed

Lead Product(s) : Monomethyl Auristatin E-Conjugated Antibody

Therapeutic Area : Oncology

Highest Development Status : Preclinical

Recipient : McSAF

Deal Size : Undisclosed

Deal Type : Collaboration

McSAF and Novasep Announce Their Successful Collaboration To Produce A Next-generation Antibody-Dr...

Details : Novasep has successfully optimized and scaled-up the process of Adcitmer® (monomethyl auristatin E-conjugated antibody), McSAF Inside® Oncology’s first-in-class proprietary ADC to treat neuroendocrine cancers.

Brand Name : Adcitmer

Molecule Type : Large molecule

Upfront Cash : Undisclosed

November 18, 2021

03 Axplora

Germany

Cosmoprof

Not Confirmed

Lead Product(s) : Teriflunomide

Therapeutic Area : Immunology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Breckenridge Pharmaceutical

Deal Size : Not Applicable

Deal Type : Not Applicable

Teriflunomide – API and Licensing Agreements for Tablets Available

Details : The received FDA approval will allow Breckenridge, to launch generic Teriflunomide in the US market from the beginning of 2023 onwards. Teriflunomide, a small molecule is a generic of Aubagio® available in 7mg & 14mg Tablets.

Brand Name : Teriflunomide-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 06, 2021

04 Axplora

Germany

Cosmoprof

Not Confirmed

Lead Product(s) : OTOF-GT,Aav Vectors

Therapeutic Area : Genetic Disease

Highest Development Status : Preclinical

Partner/Sponsor/Collaborator : Sensorion

Deal Size : Undisclosed

Deal Type : Agreement

Sensorion and Novasep Announce Signature of a Gene Therapy Product Development and Manufacturing A...

Details : Novasep will be in charge of developing and manufacturing the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies.

Brand Name : OTOF-GT

Molecule Type : Cell and Gene therapy

Upfront Cash : Undisclosed

October 27, 2020

05 Axplora

Germany

Cosmoprof

Not Confirmed

Lead Product(s) : LYS-GM101

Therapeutic Area : Genetic Disease

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Lysogene

Deal Size : Undisclosed

Deal Type : Collaboration

Novasep and Lysogene Announce their New Collaboration for Development and Production of GM1 Gangli...

Details : With this collaboration, the two companies consolidate their long-lasting partnership initiated with the development and manufacturing of Lysogene's lead gene therapy product, LYS-SAF302, currently in clinical phase 2/3.

Brand Name : Undisclosed

Molecule Type : Cell and Gene therapy

Upfront Cash : Undisclosed

May 26, 2020