In this week’s news, pharma sales growth to slow, GSK and AZ team on PAT-filled pill plant, concerns about ICH Q12 draft and more…

Competition will slow pharma sales to 2022 and force R&D rethink says expert

Competition and price pressure will slow drug revenue growth says strategist, Graham Lewis.

Lewis, who works for IQVIA, made the prediction at DCAT in New York. He cited competition in the US as the key factor, explaining industry sales will grow only 2 to 3% a year through to 2022.

Lewis said drugs for diabetes, high blood pressure and depression would see most generic competition. He also pointed out that new products for such diseases launch at lower prices as firms try to win market share.

The European and Japanese markets will see similar dynamics Lewis said. He forecast growing payer preference for non-branded medicines. So called ‘pharmerging’ markets are also seeing more generic launches.

Refocus R&D

Speciality drugs – also called orphan drugs – treat diseases affecting fewer people. Such products usually command higher prices.

A growing number of biopharma companies are focusing on these higher value, low volume products. According to Lewis, such drugs are less likely to face generic competition.

Read the full article here.

Auf wiedersehen PAT problems? GSK, AZ and CPI team on pill plant

GSK, AstraZeneca and the CPI have teamed-up to build a pill plant kitted out with process analytical technologies.

The facility – at the CPI’s County Durham site, will use continuous wet granulation to make oral drugs. The CPI said GEA, Siemens and Kaiser Optical Systems are also involved in the project.

The CPI said the plant is a “PAT-enabled” centre for drug firms developing solid dosage forms.

CPI formulation director Graeme Cruickshank said, “Creating the infrastructure needed to develop UK-led fundamental learning in this high value area will enable us to drive innovation.”

Jason Crooks from GSK said the plant “will provide a much-needed springboard to accelerate incubation and translation of emerging process analytical technologies to the pharma business.”

AstraZeneca’s Kevin Sutcliffe said, “the PAT test bed on the PROSPECT CP platform will enable industry to acquire process data using new and existing analytical technologies.”

Read the full CPI release here.

Industry concerned about ICH Q12 draft

Drug industry groups have raised concerns that the ICH Q12 draft guideline does not align with laws in certain ICH regions.

The US FDA published the ICH Q12 draft guideline in March. The aim is to help firms manage post-approval chemistry, manufacturing and controls (CMC) changes for drug substances and products.

According to Pharmaintelligence industry groups have expressed concerns about the draft guidelines. Many of the comments relate to potential problems implementing key concepts such as established conditions and product life cycle management under existing laws.

Read more here (subscription required).

Also in the news

PharmaIntelligence covered the progress of a US Bill that would require drug firms to justify price increases.

US President Donald Trump wants federal agencies to submit non-binding guidance documents to the White House budget office for review. The move would impact the FDA according to Politico.

The US FDA shared the minutes of its bi-annual meeting with the generics industry. See here.

Lonza has partnered with Chr. Hansen to set up what they claim is the first live biotherapeutic products CDMO. Read more at Bioprocess Insider.

The WHO has asked member states to do much to improve drug price transparency. See the HAI announcement here.

And finally some developments in the CDMO sector. Paragon biosciences has opened a cell and gene therapy manufacturing facility.

Catalent has opened another clinical trial supply manufacturing facility in Shanghai and Cambrex has made a new high potency API production plant operational.