News provided by Inceptua Group on Monday 15th Aug 2022
We believe there is great potential for Apealea, and the launch in Germany is an important milestone for Inceptua. LUXEMBOURG – 15 August 2022 – Inceptua Group – pharmaceutical company and service partner – today announced that Apealea® (paclitaxel micellar) has a published national price listing and is now available in Germany for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer in combination with carboplatin. Apealea is the first Cremophor-free formulation of paclitaxel approved in combination with carboplatin for ovarian cancer1. Inceptua has the exclusive right to distribute and commercialize Apealea in the EU, Norway, Iceland, Liechtenstein, Switzerland, and the UK. Stefan Fraenkel, Chief Executive Officer, Inceptua Group, says: 
“We look forward to bringing this treatment to patients as we continue our launch of Apealea throughout Europe. We believe there is great potential for Apealea, and the launch in Germany is an important milestone for Inceptua.”  
Clive Whitcher, Head of Inceptua Pharma, says: 
“With the launch of Apealea in Germany, first relapse ovarian cancer patients now have a treatment option that provides a Cremophor-free formulation, reducing the need for mandatory premedication and offering a shorter infusion time.”   
About Ovarian Cancer 
Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs.2 Globally, it is the third most common cancer among women and has the highest mortality rate3,4. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly5,6. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis7. About Apealea® (paclitaxel micellar) 
Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first Cremophor-free formulation of paclitaxel approved in combination with carboplatin for use in first relapse ovarian cancer1. Apealea is a patented, water-soluble, intravenously injectable formulation that can be given with reduced premedication such as steroids and with a shorter infusion time1. In the pivotal trial OAS-07OVA, Apealea was shown to be non-inferior to Cremophor-based paclitaxel for Progresion Free Suival (PFS) and Overall Survival8. An ad-hoc subgroup analysis suggests a significant benefit of Apealea for PFS in patients with first relapse but not in the small subpopulation with second relapse8. About Inceptua Group 
Inceptua Group is a specialty pharmaceutical company and global service partner. Inceptua Pharma commercializes and markets orphan and specialty care products and have the expertise and capabilities to supply unlicensed medicines globally. The service business units, Inceptua Clinical Trial Supply and Inceptua Early Access, support pharma and biotech companies with global clinical trial comparator sourcing, packaging, labelling, and distribution solutions and strategy, design and implementation of global early access programs (pre-approval, managed access, compassionate use). Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience, and has global operations with local offices across Europe, North America, and Asia. Additional information is available at: www.inceptua.com 
About Elevar Therapeutics 
Elevar Therapeutics is a rapidly growing, fully integrated biopharmaceutical company whose mission is to elevate treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. With offices in Utah, California, Ireland and South Korea, Elevar has multiple drug candidates in clinical development in multiple oncology therapy areas. In 2020, it licensed European distribution and commercialization of Apealea to Inceptua. Additional information is available at www.elevartherapeutics.com. About Vivesto AB 
Vivesto is a specialty pharmaceutical company focused on the development of new therapeutic options for patients suffering from hard-to-treat cancers. It has a growing pipeline of clinical-stage assets targeting late-stage cancers. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. Vivesto’s shares are traded on Nasdaq Stockholm (VIVE). To find out more about Vivesto please visit www.vivesto.com 
For further information, please contact: 
Inceptua Media Contact:

Apealea® (paclitaxel micellar) is now available in Germany for the treatment of ovarian cancer

TM & Partners has advised Vivesto on the deal. Vivesto AB completed a fully guaranteed rights issue of SEK 151 million. Danske Bank A/S, Sverige filial acted […]

Vivesto’s SEK 151 Million Fully Guaranteed Rights Issue

Vivesto AB announces that it is advancing research into its drug delivery formulations and has signed a research agreement with Visikol Inc., U.S. contract research services provider (CRO).

Vivesto signs agreement with CRO to evaluate anti-cancer drug formulations

Josh Sullivan
Associate Editor
The mRNA boom has been beneficial for CDMOs, and Lonza is no different. It’s upgraded three of its sites — two in Europe and one in New Hampshire — since landing deals with Moderna to produce the biotech’s Covid-19 vaccine, and is being considered one of the bigwigs that will be responsible for more than half of the world’s drug capacity by 2025. And last week, the Swiss drugmaker inched closer to that goal, when it announced the completion of a massive upgrade at a Nansha, China manufacturing site. The upgrade will expand the company’s ability to manufacture highly potent active pharmaceutical ingredients, and a deal has already been signed with Oasmia Pharmaceuticals to make its ovarian cancer drug candidate. That will start later this month. Christian Dowdeswell
Christian Dowdeswell, Lonza’s VP of commercial development for small molecules, talked to me about the intricacies of HPAPIs and the importance of having a presence in China. Here’s our conversation. What are some of the things that make the development and manufacturing of HPAPIs complicated? Due to its high toxicity, highly potent APIs are harmful, which means that manufacturing them requires an extremely strict containment and handling procedure to ensure the safety of engineers and an efficient technology transfer. This requires sophisticated facility designs, a protective strategy, as well as a well-trained workforce — which may be difficult to establish in-house. This is especially true for emerging companies who are more focused on improving the science of their compounds rather than manufacturing it. What are some of the benefits that comes with having this site located in China? For over 20 years, Lonza has had a presence in China and over time we have expanded our services to meet the needs of our customer portfolio of EMEA and US-headquartered customers. Our recently expanded HPAPI capabilities in Nansha allow us to continue leveraging world-class, high-quality and reliable local suppliers of raw materials to help for speedy problem-solving and manufacturing for our global network. The biopharma ecosystem in China is rapidly developing and our site helps us stay on the pulse on the market to support our global customers. Can you tell me if other deals with companies have been signed? Are more on the way? As of today, we have signed a partnership with Swedish company Oasmia Pharmaceutical AB to deliver cGMP-standard drug substance for their ovarian cancer drug candidate Cantrixil. We look forward to supporting our US- and Europe- headquartered partners at our Nansha site to support the success of their HPAPIs. Is there anything else important about this deal that readers should know? Lonza is an established partner in developing and manufacturing HPAPI, with more than 20 years’ experience in safely progressing more than 30 products from early-stage work to late-stage clinical or commercialization. The company has the capabilities in place to safely handle HPAPI to exposure levels up to 100ng/m3 across all manufacturing scales. With recent acquisitions, Lonza has also added particle engineering — micronization and spray drying — for improving bioavailability and final drug product formulation under full containment. The investment in China therefore complements Lonza’s range of HPAPI capabilities from development to commercial scale manufacturing, including formulation and delivery, with our investments in both technology and scale to ensure that we enable our customers to bring new medicines to patients faster. AUTHOR
Amber Tong
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Q&A: Lonza's Christian Dowdeswell talks HPAPIs and the Oasmia deal

03/21/2022 | 02:08am EDT
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The collaboration is projected to take Cantrixil through the planned Phase II clinical trial
Manufacturing to begin in March 2022 at Lonza's HPAPI manufacturing laboratories in Nansha, China
Solna, Sweden and Basel, Switzerland, 21 March 2022 - Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, announced today that the companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil. Cantrixil, an intraperitoneally administered drug in development for the treatment of late-stage ovarian cancer, was licensed by Oasmia from the Australian pharmaceutical company Kazia in 2021, having successfully completed a Phase I trial. Ovarian cancer is one of the most aggressive cancers and is difficult to treat in advanced stages. The Phase I study of Cantrixil demonstrated the potential for it to provide prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells' death and sensitizing cancer cells to standard chemotherapy. Oasmia is now preparing for the initiation of a Phase II trial of Cantrixil in advanced ovarian cancer. Under the terms of the agreement, Lonza will provide kilogram-scale synthesis, purification, and stability testing of Cantrixil, and deliver cGMP batches of drug substance for clinical supply. Oasmia will leverage Lonza's extensive experience and expertise in manufacturing highly-potent API (HPAPI). The drug substance will be manufactured at Lonza's recently expanded production facility at Nansha, China. Manufacturing is expected to begin in March 2022. Kai Wilkinson, Chief Technical Officer at Oasmia, commented:"We are excited to have partnered with Lonza,  a global leader in drug manufacturing. The manufacture of Cantrixil is planned to be performed in three steps and this agreement is the first and most crucial step in us securing the clinical drug supply for its development. "Christian Dowdeswell, VP and Global Head, Commercial Development - Small Molecules, Lonza, added: "Our team has extensive experience supporting the development and manufacture of challenging molecules. We are looking forward to collaborating with Oasmia to advance this promising drug candidate in the clinic." Attachments

Lonza : Oasmia Signs Manufacturing Agreement with Lonza for Ovarian Cancer Drug Candidate Cantrixil

Lonza Group (SIX: LONN) (SGX: O6Z) is a chemicals and biotechnology company that provides product development services to the pharmaceutical and biologics industries, including organic, fine, and performance chemicals. It was founded in 1897 and is based in Basel, Switzerland.

Lonza Group

Lonza is an established partner in developing and manufacturing HPAPI , with more than 20 years ' experience in safely progressing more than 30 products from early-stage work to late-stage clinical or commercialization .

taiba is a healthcare marketing, distribution & retail pharmacies group in the Sultanate of Oman.

taiba

Karo Pharma offers a range of everyday healthcare products and services that helps to overcome illness and treat health ailments. It develops and markets products for pharmacies, grocery stores, and direct to the healthcare sector. Karo Pharma focuses on developing products for older people. The company was founded in 1987 and is based in Stockholm, Sweden.

Karo Pharma

Abbott (NYSE: ABT) is a global healthcare company with a portfolio of science-based offerings in diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals.

Abbott

TitanX

Dynapac

Atlas Copco

Pharmaceutical and biotechnology companies with cancer therapy drug candidates.

Cancer

Oasmia Pharmaceutical develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents.

Name	Michael af Winklerfelt
Work History	TitanX, Dynapac, and Atlas Copco
Title	Chief Financial Officer
Status	Former

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