Out-Licensing

Andrea Iavasile-Sauter, Tender Manager Out-Licensing, explains why out-licensing goes beyond products

Pharmaceutical out-licensing goes beyond products. In countries such as Germany, the Netherlands and New Zealand, for example, health insurance companies procure their pharmaceuticals through tender contracts. We pride ourselves in being strong players in this challenging business with high volumes and competitive prices.

Elena Biry, Project Manager Acino Out-Licensing, on business opportunities for European markets

In today’s pharmaceutical market, customers increasingly demand new high-quality products. That’s why at Acino we invest in the acquisition of new dossiers and co-development projects, and are actively looking for reliable partners to establish long-term relationships and co-develop products.

Sibylle Graf, Head of Out-Licensing, envisions a new era for Acino Out-Licensing

We have come to a turning point where the older molecules will be gradually replaced by new generation molecules in indications such as cardiovascular, neurology, urology and pain.

There is so much behind affordable medicines. Take the pharmaceutical tender business for example, which can make medicines less expensive for patients, and also more readily available as healthcare insurers and institutions seek the best value. We manage and help our customers tender with quality, integrity and transparency for a full value chain that benefits them and the patients.

Pharmaceutical out-licensing goes beyond products. In countries such as Germany, the Netherlands and New Zealand, for example, health insurance companies procure their pharmaceuticals through tender contracts. We pride ourselves in being strong players in this challenging business with high volumes and competitive prices.

Meet Andrea Iavasile-Sauter, Tender Manager Out-Licensing. Reach out via the contact section below.

In today’s pharmaceutical market, customers increasingly demand new high-quality products. That’s why at Acino we invest in the acquisition of new dossiers and co-development projects, and are actively looking for reliable partners to establish long-term relationships and co-develop products.

We are committed to bringing new molecules from a timely development and scaling-up to a successful bioequivalence study and registration. All with the backing of Acino’s strong market presence and tender track record, as well as our highly skilled multifunctional teams.

If you are interested in a partnership or would like to discuss business opportunities with Acino, reach out to our team. We are looking forward to working with you.

Elena Biry

Project Manager Acino Out-Licensing

Out-Licensing has a long tradition at Acino. Already before it was acquired by Acino in 2004, Cimex developed generic products and licensed them out to European customers. Special focus was on difficult-to-develop molecules and pharmaceutical forms, i.e. extended release forms such as MUPS tablets, as well as narcotic products. So over the years Acino achieved a significant business with European customers and supplied products for more than 20 years to them. In recent years the tender business began to gain more and more of importance for our European partners and Acino successfully supported them in winning a majority of tenders.

Now we have come to a turning point where the older molecules should be gradually replaced by new generation molecules in indications such as cardiovascular, neurology, urology and pain. New therapeutic areas such as cancer should be considered too, as they will play a big part in the future of pharmaceutical business. This expansion into new therapeutic areas will take place with external support either through acquisition of dossiers from territories outside of Europe or by performing developments in India under the strict quality standards of Acino.

The aim is to transfer these products into our production facilities in Liesberg, Switzerland and pack them either in Switzerland or in our site in Estonia where they can also be released for the EU markets if requested.

As we are currently investing in the development of new generics we invite all companies who are interested in a co-development or offering their molecules to us to contact us directly. In a global world collaboration with partners is certainly one key element to success for both parties.

Such projects require a close project management and support from all key departments in-house (e.g. production, packaging, quality assurance, regulatory, legal) to finalize these projects in time for patent expiry together with our partners.

I am really proud of our dynamic and motivated Out-Licensing team with fresh ideas, different attitude to social media, service-oriented and proactive behaviour. It is a pleasure to work with such a team and bring projects jointly forward to the benefit of our customers and Acino.

Sibylle Graf

Head of Out-Licensing

Highlights

  • 30+Countries
  • 280Marketing Authorizations
  • Countries
  • Marketing Authorizations

Innovative generics for our pharma partners worldwide.

Acino is a Swiss-based company that offers high quality generic products in advanced drug delivery systems. Special focus is on narcotics and extended release formulations as part of our long-term strategy to expand the product portfolio within Oncology, Urology or Pain. The products are manufactured in our Swiss plants in the Basel area and packed either in Switzerland or Estonia. In individual cases, manufacture is outsourced to selected partner companies conforming to our high quality standards.

High-quality pharmaceutical products from a Swiss company
Acino has a long track record in licensing-out dossiers developed in-house to European customers, from multinationals to local players. Fully integrated services with respect to IP, market analysis, regulatory support, legal know-how and efficient supply chain can be offered to our global customers.

Everything from a single source, from us
If required, EU batch release can be handled by our Estonian or German sites. Serialization including aggregation is possible since November 2018 on and helps tracking all our products over the globe, thus avoiding falsification of medicines for the benefit of patients.

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Key functions

Acino offers fully integrated services. Whether you opt for the entire service chain or have individual needs, we provide top-quality work, something every customer can rightfully expect from us.

Legal, Compliance, and IP expertise

Our Acino Legal team supports business transactions of all kinds, including licensing agreements, supply agreements, confidentiality agreements, M&A, and more.

Our Compliance team ensures the highest standards of ethics and integrity within all the activities at Acino.

Finally, our IP team advises on Intellectual Property rights of all the pharma products worldwide.

Quality assurance

As a Swiss company, Quality is part of our DNA and we are motivated to ensure high quality products for our patients. Acino is committed to be compliant with all the applicable laws, guidelines as per cGMPs and applicable normatives ensuring the safety, efficacy and quality of our products.

Our Acino quality standards can ensure compliance not only with Swissmedic and EU GMP standards, but also with all the international markets where we operate.

All necessary aspects associated with quality, safety and efficacy of our products are governed by a number of both corporate and local documents such as Quality Manual, Quality Directives, and Standard Operating Procedures.

Regulatory

Our Regulatory department has large experience in defining the regulatory strategy in Europe for new molecules and in running DCPs, MRPs or national procedures. Maintenance of the products during their lifecycle to comply with regulations is an important task for them.

Manufacturing

Best in class drug-delivery solutions for oral solid dosage forms.

Learn more about our capabilities here.

Visit our Liesberg site virtually here.

Packaging

We pack in numerous variations:

  • Bulk
  • Blisters with foil (PP, Aclar, childproof foils, etc.)
  • Alu-alu-strip packaging
  • Sachets
  • Bottles

Our logistics facility for oral drugs in Aesch (Switzerland) is equipped with state-of-the-art packaging lines and a fully automated high bay warehouse with 8000 pallet racks.

Our two packaging facilities are located in Switzerland and Estonia and are capable to supply globally serialized and tamper proofed products to our customers.

Supply Chain

Managing the supply chain with a large variety of pack sizes, country-specific labeling and patient information in different languages is a well-established logistics task for our experienced team. Providing these services with the accustomed indisputable quality is a matter of course for our customers and rounds off our service offering.

Our efficient Supply chain team has of many years of experience in shipping goods around the world by air, sea or land and works together with reliable forwarding agents in order to deliver goods to our customers without causing problems at customs, during transportation (i.e. through cold chain) and with the aim to secure arrival in time.

Handling transportation of narcotics and procurement of all required licences for export in close cooperation with our customers is a routine job for them for many years.

Tenders - Let's win together

In certain countries (mainly in Germany, the Netherlands and New Zealand)  health insurance companies secure their demand of pharmaceuticals through tender contracts. Acino is a strong player in this challenging business with high volumes and competitive prices.

We constantly support our valued partners as they bid in tenders. Our credo is to sit together, discuss the supply and pricing situation in order to win the tender in spite of the strong competition. Furthermore, we assist with the needed documentation and our efficient supply chain makes sure that products are available in time to fulfill the contracts with health insurance companies and to avoid penalties.

Products

In order to guarantee a continuous pipeline in the therapeutic areas of interest, new products are being developed together with renowned partners worldwide under the guidance and high-quality standards of Acino and will be added to our portfolio soon.

Additionally, licenses are acquired from territories outside of Europe and products adapted to European requirements with the purpose of out-licensing them to our partners.

The following products, which are either already marketed or in registration, are currently available for out-licensing:

Active ingredient Formulation Dosage strength Therapeutic area
Alfuzosine Retard tablet 5 / 10 mg Urology
Amlodipine Tablet 5 / 10 mg Cardiovascular
Clopidogrel Film-coated tablet 75 mg Cardiovascular
Doxazosine Retard tablet 4 / 8 mg Cardiovascular
Hydromorphone Retard capsule 2 / 4 / 8 / 16 / 24 mg Pain
Itraconazole Capsule 100 mg Infectiology
Levodopa/Carbidopa
 Retard tablet 100/25; 200/50 mg Central nervous system
Macitentan (NEW) Film-coated tablet 10 mg Cardiovascular
Metoprolol Succinate Retard tablet 23.75 / 47.5 / 95 / 190 mg Cardiovascular
Metoprolol Tartrate
 Retard tablet 50/100/200 mg Cardiovascular
Oxycodone  Retard tablet 5 / 10 / 15 / 20 / 30 / 40 / 60 / 80 mg Pain
Rivaroxaban (NEW) Capsules 10 / 15 / 20 mg Cardiovascular

 

Products which are subject to patent protection are offered with respect of the prevailing patent laws. No sales, prior to the expiry date of valid patents, are foreseen to countries where patents are in force.

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Contact - Let's talk Out-Licensing