Malvern, PA, USA – November 1, 2021 – Flamma USA, part of the Flamma Group,  (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that it has completed the re-commissioning of the High Potent API (HPAPI) suite.

Flamma is confident that this will provide a viable alternative for customers seeking development of early stage HPAPIs since the long lead times for other vendors is often problematic. The Flamma team has gone through an exhaustive qualification of the HPAPI suite over the past six months in order to bring this offering to the marketplace.

“This is a strategic step for Flamma as we have been asked to explore other therapeutic areas for our customers”, said Gianmarco Negrisoli, President Flamma USA. “Recently, there has been interesting discussions about onshoring so we see this as a logical step to provide the opportunity to bring back manufacturing into the USA”.

Flamma USA has grown to 35 people and are currently working on a variety of projects for numerous companies. These projects are typically pre-clinical that often require a combination of GLP tox material that is quickly followed up with 1-5 kg of GMP material from the pilot plant. Located outside of Philadelphia, Flamma USA allows customers the ability to stay within the USA for the early development of their small molecule drug candidates.

Flamma has the ability to leverage obtaining starting materials and key intermediates from Flamma Honkai in Dalian, China. This tactic allows for Flamma Honkai to make the first few steps of the route before allowing Flamma USA to complete the GMP work in the pilot plant while potentially condensing timelines. Meanwhile, future growth can be accommodated in Italy as the project matures.

Download press release (pdf)

For further information, please visit the Flamma website at http://www.flammagroup.com.

Contact Flamma

Kenneth Drew, Ph.D., VP Flamma USA

ken.drew@flammagroup.com

1-617-515-0975

Chignolo D’Isola, Bergamo, Italy – November 5, 2020 – Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that it has entered into an agreement with Gilead earlier this year to be part of the network of manufacturers contributing to the Veklury® (remdesivir) supply chain.

Flamma will continue to use its sites in Italy and China to support the need for necessary compounds in an effort to help COVID-19  patients in need.

“Covid-19 hit very close to home as Flamma is located in the Bergamo, one of the most affected areas in Italy. Our facility in Dalian, China  remained in full operation after the extended Chinese New Year after adding proper precautions to protect the safety and health of its employees,” noted Gian Paolo Negrisoli, CEO. “Our Italian team members utilized the protocols learned from our Chinese team and instituted them in Italy. This allowed our teams there to continue to support our customers with little to no interruption to the supply chain”.

The Flamma team has strived to provide continuous manufacturing support for remdesivir, maintaining timelines for current and upcoming projects due to the global and local needs. “This pandemic brought forth many challenges but Flamma responded to all of them with dedication and a team spirit by working tirelessly to be a part of the pharmaceutical supply chain to help those in need” notes Kenneth Drew, Ph.D., VP Flamma, USA.

During the Covid-19 crisis, Flamma teams in Italy and China have continued production of important molecules that are critical to help fight the virus. The Italian team hung a sign reading #MOLAMIA which means ‘Don’t Give Up’. Flamma doesn’t give up. This is another example of the commitment, made to not only customers but employees, to be a first-class organization. Flamma is very proud of the opportunity to support Gilead and remdesivir in the fight against Covid-19, and will continue to do all it can to be active partner in the development of breakthrough treatments.

About Veklury® (remdesivir):

Veklury (remdesivir) is an investigational nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of COVID-19. Based on available data from these studies, Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. Additional ongoing international clinical trials continue to further evaluate the safety and efficacy of Veklury in different patient populations and formulations, and in combination with other therapies.

About Flamma:

FLAMMA is a family owned & run, fully integrated CDMO based in Bergamo (near Milan in Northern Italy) established in 1950.

FLAMMA is a company specialized in the cGMP manufacture of APIs, NCEs, RSMs, and advanced intermediates for the pharmaceutical industry. Flamma has particular expertise in high value chiral materials specifically amino acid related materials. Flamma also manufactures specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries and has several generic products.

FLAMMA has four manufacturing facilities all with R&D labs- Italy (2), China, and the USA. Both cGMP Italian locations (Chignolo & Isso) are regularly inspected by the FDA and AIFA. Flamma Honkai, located in Dalian, China, has a new R&D building as well as a cGMP production plant. Flamma provides security when working in China with our 100% owned, self-managed facilities that deliver results without worry. Flamma reliably supplies materials directly to customers and/or delivers materials to its cGMP facilities in Italy in order to deliver the customer’s compound on-time and with the desired specifications. Flamma offers cost-effective services to customers looking for a trusted partner within China.

The Malvern, PA site located outside Philadelphia provides Flamma with the ability to service customers looking to keep materials within the USA for pre-clinical/early stage clinical development as well as small scale commercial manufacturing.

Being a fully integrated company allows Flamma to move your compounds quickly along their journey taking into consideration all aspects necessary for the success of your project.

Flamma can be of assistance for early stage pre-clinical development of small molecules as well as for large-scale commercial manufacturing. With a total reactor capacity of 450 m³ and over 600 employees, see why Flamma should be your next contract manufacturer. FLAMMA – THE THINKING CDMO^TM.

Chignolo D’Isola, Bergamo, Italy – October 2020: Flamma CEO Gian Paolo Negrisoli gives his views on the industry and Flamma in the latest issue of Chemistry Today. This issue focuses on the Italian Pharma Outlook.

Please go to Chemistry Today to see the article using this link:

Chemistry Today October 2020 issue

Chignolo D’Isola, Bergamo, Italy – September, 2020: Flamma was selected as one of the Welfare Champion 2020 companies that obtained the 5 W of the PMI Welfare Index rating and which constitutes the backbone of the Italian economic fabric.

The Welfare Index PMI is the initiative, promoted by Generali Italia with the participation of the major Italian confederations – Confindustria, Confagricoltura, Confartigianato, Confprofessioni, Confcommercio – to spread the culture of corporate welfare among companies. Obtaining a 5 W means that the company has:

* relevant welfare breadth (at least 8 areas among those identified)

* high intensity (several initiatives for each area)

* orientation to social innovation

* relevant economic and organizational commitment

* involvement of workers

The Index is scientifically constructed: research criteria and methodology are subjected to the control of a Steering Committee made up of all the partner trade associations of the project, institutional representatives and experts from industry and academia.

Extraordinary stories of companies that have placed health and safety at the center of their corporate objectives and have increased their commitment also in assistance, training, work-life balance.

Businesses have been the immediate point of contact for employees, their families, and communities. These are realities characterized by the widest welfare system (by number of activated areas) and which are characterized by the number and intensity of initiatives, degree of employee involvement and economic and organizational commitment to corporate welfare. In particular, this year the Welfare Champions have shown great ability to react and resilience to the impact of the Covid crisis.

Here is a video:  https://youtu.be/-oDWuDqr8AQ

Full post: https://www.flammagroup.com/flamma-selected-as-a-2020-welfare-champion-recipient/

As part of their Wednesday Chats, TKS Publishing interviewed Gianmarco Negrisoli, President of Flamma USA, on July 8, 2020. This short video interview gives one a glimpse of what Flamma is all about. If you have about ten minutes, it is worth your time.

Chignolo D’Isola, Bergamo, Italy – June 19, 2020 – Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, will bring forth a novel way to learn about Flamma and their offerings. Beginning June 26^th, Flamma will host a series of 15 minute informational meetings online every 4^th Friday of the month.

There will be no need to register or sign in since the online experience will take place in a virtual meeting room. This allows people to take advantage of the technology available to us yet remain anonymous. Flamma values your privacy and does not feel it is useful to have one sign up with their full contact information to learn about Flamma’s offerings.

This series of virtual meetings will allow those located in varying time zones to selected what time works for them. There will be three separate meetings held on the following Fridays: June 26, July 24, August 28, September 25 and October 23 at the following times:

9:00AM ET/15:00 CET (morning on the East Coast, afternoon in Europe)

8:00AM PT/11:00AM ET/17:00 CET (morning on the West Coast, evening in Europe)

11:00AM PT/2:00PM ET (late morning on the West Coast, afternoon on the East Coast)

Join anonymously using the following link: https://pexip.me/meet/0148100399

During these challenging times, there are still pharmaceutical projects that need to move forward thus finding the right outsourcing partner is critical. Flamma wants to provide sourcing professionals, CMC team leaders, executives from large and small companies and anyone else (including competitors) the opportunity to expand their CDMO portfolio.

Chignolo D’Isola, Bergamo, Italy – May 21, 2020 – Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce the ground breaking for their new R&D building. While most CEOs use a gold plated shovel, Flamma’s CEO Gian Paolo Negrisoli, used an excavator to mark the groundbreaking of the new R&D Building at Flamma’s headquarters in Chignolo d’Isola, Bergamo, Italy.

This marks the expansion at Flamma’s headquarters that will allow Flamma to quadruple its R&D space. The R&D building will accommodate 50 additional employees providing additional R&D and analytical development laboratories as well as offices and meeting rooms. In addition to these features, there will be a lab for high containment and special chemistries.

During the Covid-19 crisis of 2020, our teams in Italy and China worked tirelessly to continue production of important molecules that are critical to help fight the virus. The Italian team hung a sign reading #MOLAMIA which means ‘Don’t Give Up’. Flamma doesn’t give up. This important milestone is another example of the commitment made to not only customers but employees to deliver a first class organization where people want to place their projects.

The new R&D building will serve as a complement the R&D work being done at Flamma USA in Malvern, PA outside of Philadelphia. The team in the USA continues to grow as more projects come on board. For further information, please visit the Flamma website at http://www.flammagroup.com.

View a one minute video here: https://vimeo.com/424568102

Chignolo D’Isola, Bergamo, Italy – April 16, 2020 – Flamma has been named the Best Global Pharmaceutical CDMO according to the 2020 Biotechnology Awards.

Read more at: https://www.ghp-news.com/issues/biotechnology-awards-2020/

Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, would like to thank the 2020 Biotechnology Awards for their selection of Flamma. This is a testament to the entire Flamma team.

Chignolo D’Isola, Bergamo, Italy – April 6, 2020 – Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that Flamma has been named a Top 10 CMO in Europe by Pharma Tech Outlook. Read more at:

https://cmo-europe.pharmatechoutlook.com/vendor/flamma-group-spearheading-the-pharma-supply-chain-cid-681-mid-64.html

March 11, 2020

Re: Covid-19 outbreak and impact to Flamma Italy

Dear Partners and Friends,

I would like to reach out and provide you with a better picture of what the situation looks like in Italy and at Flamma. As you are reading in the newspapers, the situation in Italy is worsening every day: infections are growing exponentially and we don’t know when the peak will hit. The majority of the people infected manifest light symptoms and can be cured at home but many still need hospitalization and, a few, but still too many, are critical and need Intensive Care Units, unfortunately for weeks and not for days.

As Italian, I’m very proud of our Healthcare system but with these numbers even the best system will collapse and we are very close to this point. When my friends at hospital say that they’ll need soon to select which patients can be admitted and which not, you can understand that we reacted too little and too late.

As many others, I underestimated the danger. I thought that doctors words were exaggerated and with few precautions, we would have been safe from Covid19. Now, I can say that it was a big mistake because infections are still growing and the latest measures taken by the government were extremely necessary to stop the infection growth. Unfortunately the impact on our activity is extremely significant.

Flamma, till now, worked at full stream despite the emergency as well as the seasonal flu which typically reduces the workforce. We are now compelled to slow down the production from next week because the transportation of raw materials, mainly solvents, will worsen and because we are facing a progressive reduction of our workforce.

As of today no employee has tested positive for the virus. We took important measures to prevent infections inside the company. These include: 20% of our employees are currently working remotely from home; we have completely segregated teams on shifts in Production, QC, and RD, limiting contacts between these teams; we are doing sanitization between shifts in the changing room; enforcing strict rules for accessing to the cafeteria and break areas and reviewing procedures to work at distance; we manufactured large volumes of liquid sanitizer because it’s not available in the market , like masks : we are now buying them from china after having sent thousands to Honkai last month. Situation in China has significantly improved, thanks to the very strong measures implemented. Flamma Honkai now works at full stream and is delivering without issues by air and, with some delays, by sea.

I’m writing you this letter asking you to not underestimate the Coronavirus issue. The curve of infections in other countries is already similar to what we had in Italy some days ago and, I suppose, in the USA it will likely happen with a one or two week delay. Please take immediate decisions that we took too late and follow the most basic rules by especially limiting exposure to public areas.

At Flamma, we feel we are on the front line to deliver treatment to patients who need it now more the ever. We plan to continue our activity until we are able to guarantee the health and safety of our people. There will be for sure some delays but I want to assure you that the entire Flamma team is highly committed in delivering what is most needed now. It will be our duty to inform you immediately if the situation changes in the next few days.

I want to thank you for your support in this difficult time and for your trust in Flamma as a partner.

Sincerely,

Gian Paolo Negrisoli

President and CEO